Skip to content

Study · Randomized controlled trial · 2003

14 results

The effect of teriparatide [human parathyroid hormone (1-34)] therapy on bone density in men with osteoporosis.

Orwoll ES, Scheele WH, Paul S, Adami S, Syversen U, Diez-Perez A, Kaufman JM, Clancy AD, Gaich GA

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1 Jan 2003Cited by 454 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study14

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanRandomized controlled trialMechanism

    In men with osteoporosis, teriparatide increased biochemical bone formation markers early during therapy.

    In plain wordsIn men with osteoporosis, bone formation markers increased during teriparatide treatment.

    Outcome
    IncreaseBone formation markers
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · injection · Median 11 monthsAs given in this study (human).

    Source sentences

    Summary
    Biochemical markers of bone formation increased early in the course of therapy and were followed by increases in indices of osteoclastic activity.
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  2. 02HumanRandomized controlled trialMechanism

    In men with osteoporosis, increases in osteoclastic activity indices followed increases in bone formation markers during teriparatide therapy.

    In plain wordsIn men with osteoporosis, bone breakdown activity increased after bone formation markers increased during teriparatide treatment.

    Outcome
    IncreaseOsteoclastic activity indices
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · injection · Median 11 monthsAs given in this study (human).

    Source sentences

    Summary
    Biochemical markers of bone formation increased early in the course of therapy and were followed by increases in indices of osteoclastic activity.
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In men with osteoporosis, spine bone mineral density exceeded placebo after three months of teriparatide treatment.

    In plain wordsIn men with osteoporosis, teriparatide increased spine bone density compared with placebo at the early assessment.

    Outcome
    IncreaseSpine bone mineral density at early assessment
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · injection · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Spine bone mineral density was greater than in placebo subjects after 3 months of teriparatide therapy, and by the end of therapy it was increased by 5.9% (20 microg) and 9.0% (40 microg) above baseline (p < 0.001 vs. placebo for both comparisons).
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In men with osteoporosis, lower-dose teriparatide increased spine bone mineral density by 5.9% from baseline, significantly more than placebo.

    In plain wordsIn men with osteoporosis, lower-dose teriparatide increased spine bone density more than placebo.

    Outcome
    IncreaseSpine bone mineral density, lower dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 microg daily · injection · Median 11 monthsAs given in this study (human).

    Measurements

    Spine BMD increase
    5.9%
    20 microg, above baseline

    Source sentences

    Summary
    Spine bone mineral density was greater than in placebo subjects after 3 months of teriparatide therapy, and by the end of therapy it was increased by 5.9% (20 microg) and 9.0% (40 microg) above baseline (p < 0.001 vs. placebo for both comparisons).
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In men with osteoporosis, higher-dose teriparatide increased spine bone mineral density by 9.0% from baseline, significantly more than placebo.

    In plain wordsIn men with osteoporosis, higher-dose teriparatide increased spine bone density more than placebo.

    Outcome
    IncreaseSpine bone mineral density, higher dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    40 microg daily · injection · Median 11 monthsAs given in this study (human).

    Measurements

    Spine BMD increase
    9%
    40 microg, above baseline

    Source sentences

    Summary
    Spine bone mineral density was greater than in placebo subjects after 3 months of teriparatide therapy, and by the end of therapy it was increased by 5.9% (20 microg) and 9.0% (40 microg) above baseline (p < 0.001 vs. placebo for both comparisons).
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In men with osteoporosis, lower-dose teriparatide increased femoral neck bone mineral density by 1.5% above baseline.

    In plain wordsIn men with osteoporosis, lower-dose teriparatide increased femoral neck bone density compared with baseline.

    Outcome
    IncreaseFemoral neck bone mineral density, lower dose
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 microg daily · injection · Median 11 monthsAs given in this study (human).

    Measurements

    Femoral neck BMD increase
    1.5%
    20 microg, above baseline

    Source sentences

    Summary
    Femoral neck bone mineral density increased 1.5% (20 microg; p = 0.029) and 2.9% (40 microg; p < 0.001), and whole body bone mineral content increased 0.6% (20 microg; p = 0.021) and 0.9% (40 microg;p = 0.005) above baseline in the teriparatide subjects.
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In men with osteoporosis, higher-dose teriparatide increased femoral neck bone mineral density by 2.9% above baseline.

    In plain wordsIn men with osteoporosis, higher-dose teriparatide increased femoral neck bone density compared with baseline.

    Outcome
    IncreaseFemoral neck bone mineral density, higher dose
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    40 microg daily · injection · Median 11 monthsAs given in this study (human).

    Measurements

    Femoral neck BMD increase
    2.9%
    40 microg, above baseline

    Source sentences

    Summary
    Femoral neck bone mineral density increased 1.5% (20 microg; p = 0.029) and 2.9% (40 microg; p < 0.001), and whole body bone mineral content increased 0.6% (20 microg; p = 0.021) and 0.9% (40 microg;p = 0.005) above baseline in the teriparatide subjects.
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In men with osteoporosis, lower-dose teriparatide increased whole-body bone mineral content by 0.6% above baseline.

    In plain wordsIn men with osteoporosis, lower-dose teriparatide increased whole-body bone mineral content compared with baseline.

    Outcome
    IncreaseWhole-body bone mineral content, lower dose
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 microg daily · injection · Median 11 monthsAs given in this study (human).

    Measurements

    Bone mineral content increase
    0.6%
    20 microg, above baseline

    Source sentences

    Summary
    Femoral neck bone mineral density increased 1.5% (20 microg; p = 0.029) and 2.9% (40 microg; p < 0.001), and whole body bone mineral content increased 0.6% (20 microg; p = 0.021) and 0.9% (40 microg;p = 0.005) above baseline in the teriparatide subjects.
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In men with osteoporosis, higher-dose teriparatide increased whole-body bone mineral content by 0.9% above baseline.

    In plain wordsIn men with osteoporosis, higher-dose teriparatide increased whole-body bone mineral content compared with baseline.

    Outcome
    IncreaseWhole-body bone mineral content, higher dose
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    40 microg daily · injection · Median 11 monthsAs given in this study (human).

    Measurements

    Bone mineral content increase
    0.9%
    40 microg, above baseline

    Source sentences

    Summary
    Femoral neck bone mineral density increased 1.5% (20 microg; p = 0.029) and 2.9% (40 microg; p < 0.001), and whole body bone mineral content increased 0.6% (20 microg; p = 0.021) and 0.9% (40 microg;p = 0.005) above baseline in the teriparatide subjects.
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  10. 10HumanRandomized controlled trialEfficacy outcome

    In men with osteoporosis, radial bone mineral density did not change during teriparatide treatment.

    In plain wordsIn men with osteoporosis, teriparatide did not change radial bone density compared with baseline.

    Outcome
    No significant changeRadial bone mineral density
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · injection · Median 11 monthsAs given in this study (human).

    Source sentences

    Summary
    There was no change in radial bone mineral density in the teriparatide groups.
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  11. 11HumanRandomized controlled trialOther

    In men with osteoporosis receiving teriparatide, the abstract reported expected mineral metabolism changes without specifying their direction.

    In plain wordsIn men with osteoporosis receiving teriparatide, mineral metabolism changed, but the abstract did not specify how.

    Outcome
    Direction not reportedMineral metabolism
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · injection · Median 11 monthsAs given in this study (human).

    Source sentences

    Summary
    Subjects experienced expected changes in mineral metabolism.
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  12. 12HumanRandomized controlled trialSafety outcome

    In men with osteoporosis, adverse events were similar with lower-dose teriparatide and placebo.

    In plain wordsIn men with osteoporosis, lower-dose teriparatide and placebo had similar adverse event frequency.

    Outcome
    No significant changeAdverse events, lower dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 microg daily · injection · Median 11 monthsAs given in this study (human).

    Source sentences

    Summary
    Adverse events were similar in the placebo and 20-microg groups, but more frequent in the 40-microg group.
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.
  13. 13HumanRandomized controlled trialSafety outcome

    In men with low bone density, adverse events were more frequent with teriparatide 40 microg than in the placebo and 20-microg groups.

    In plain wordsIn men with low bone density, adverse events were more frequent with teriparatide 40 microg than with placebo or 20 microg.

    Outcome
    IncreaseAdverse events, higher dose versus placebo
    Study

    n: not reported in source

    Comparator
    Placebo and teriparatide 20 microg groups
    Outcome group
    Adverse events · Whole body
    Studied dose
    40 microg daily · injection · Median 11 monthsAs given in this study (human).

    Source sentences

    Summary
    Adverse events were similar in the placebo and 20-microg groups, but more frequent in the 40-microg group.
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.

Studies that did not test the peptide alone1

In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Teriparatide (PTH 1-34).

  1. 14HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyEfficacy outcome

    In men with osteoporosis, teriparatide bone density responses were similar across gonadal status, age, baseline density, body mass, smoking, and alcohol intake.

    In plain wordsIn men with osteoporosis, bone density responses to teriparatide were similar across the reported patient characteristics.

    Outcome
    No significant changeBone mineral density response across patient characteristics
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    Bone mineral density responses to teriparatide were similar regardless of gonadal status, age, baseline bone mineral density, body mass index, smoking, or alcohol intake.
    3 context sentences
    Summary · context
    We randomized 437 men with spine or hip bone mineral density more than 2 SD below the young adult male mean to daily injections of placebo, teriparatide 20 microg, or teriparatide 40 microg.
    Summary · context
    All subjects also received supplemental calcium and vitamin D.
    Summary · context
    The study was stopped after a median duration of 11 months because of a finding of osteosarcomas in rats in routine toxicology studies.

    In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 not yet recruiting · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase 1/2NCT06303284

PROactive HEALing in High-Risk Pelvic and Non-hip Lower Extremity Fragility Fractures (PRO HEAL Pilot)

University of Calgaryn = 54est. 15 Mar 2027 to est. 17 Mar 2031

Lower Extremity Fractures · Pelvis · Acetabulum

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.