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Study · Randomized controlled trial · 2007

9 results

Effect of recombinant human parathyroid hormone (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial.

Greenspan SL, Bone HG, Ettinger MP, Hanley DA, Lindsay R, Zanchetta JR, Blosch CM, Mathisen AL, Morris SA, Marriott TB

Annals of internal medicine1 Mar 2007Cited by 298 (Europe PMC)

PMID17339618 (opens in a new tab)DOI10.7326/0003-4819-146-5-200703060-00005 (opens in a new tab)PepBankPUB-17339618
Publisher pagePubMedAsk about this study
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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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In osteoporotic postmenopausal women, PTH reduced vertebral fracture risk versus placebo when noncompleters were assumed fracture-free (RR 0.42, 95% CI 0.24–0.72).

    In plain wordsIn osteoporotic women, PTH reduced vertebral fracture risk versus placebo when noncompleters were assumed fracture-free.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    DecreaseVertebral fractures assuming no fractures in noncompleters
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    100 mug daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Relative risk
    0.42
    assuming no fractures
    P value
    0.001
    assuming no fractures
    95% CI of relative risk
    0.24 to 0.72
    assuming no fractures

    Source sentences

    Summary
    relative risk assuming no fractures, 0.42 [95% CI, 0.24 to 0.72] [P = 0.001]
    3 context sentences
    Summary · context
    18-month, randomized, double-blind, placebo-controlled, parallel-group study.
    Summary · context
    2532 postmenopausal women with low bone mineral density at the hip or lumbar spine.
    Summary · context
    Women received 100 mug of recombinant human PTH or placebo daily by subcutaneous injection.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In osteoporotic women, PTH had a vertebral fracture RR of 0.60 versus placebo under completer-incidence assumptions (CI 0.36–1.00, P = 0.05).

    In plain wordsIn osteoporotic women, PTH had lower estimated fracture risk than placebo under completer-incidence assumptions.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    DecreaseVertebral fractures assuming completer fracture incidence
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    100 mug daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Relative risk
    0.6
    completer fracture incidence
    P value
    0.05
    completer fracture incidence
    CI of relative risk
    0.36 to 1
    completer fracture incidence

    Source sentences

    Summary
    relative risk assuming fracture incidence observed in all patients who completed the trial, 0.60 [CI, 0.36 to 1.00] [P = 0.05]
    3 context sentences
    Summary · context
    18-month, randomized, double-blind, placebo-controlled, parallel-group study.
    Summary · context
    2532 postmenopausal women with low bone mineral density at the hip or lumbar spine.
    Summary · context
    Women received 100 mug of recombinant human PTH or placebo daily by subcutaneous injection.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In osteoporotic women, PTH had a vertebral fracture RR of 0.62 versus placebo under placebo-incidence assumptions (CI 0.37–1.04, P = 0.07).

    In plain wordsIn osteoporotic women, PTH had a lower estimated fracture risk than placebo under placebo-incidence assumptions (P = 0.07).

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    DecreaseVertebral fractures assuming placebo fracture incidence
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    100 mug daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Relative risk
    0.62
    placebo fracture incidence
    P value
    0.07
    placebo fracture incidence
    CI of relative risk
    0.37 to 1.04
    placebo fracture incidence

    Source sentences

    Summary
    relative risk assuming fracture incidence observed in the placebo group, 0.62 [CI, 0.37 to 1.04] [P = 0.07]).
    3 context sentences
    Summary · context
    18-month, randomized, double-blind, placebo-controlled, parallel-group study.
    Summary · context
    2532 postmenopausal women with low bone mineral density at the hip or lumbar spine.
    Summary · context
    Women received 100 mug of recombinant human PTH or placebo daily by subcutaneous injection.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In osteoporotic women, PTH increased spine BMD by 6.9% versus placebo (CI 6.4% to 7.4%).

    In plain wordsIn osteoporotic women, PTH increased spine bone density compared with placebo.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    IncreaseSpine BMD
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    100 mug daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Spine BMD difference versus placebo
    6.9%
    PTH vs placebo, spine
    CI of spine BMD difference
    6.4 to 7.4%
    PTH vs placebo, spine

    Source sentences

    Summary
    Compared with placebo, mean bone mineral density increased at the spine by 6.9% (CI, 6.4% to 7.4%) and at the hip by 2.1% (CI, 1.7% to 2.5%) but decreased at the forearm in the PTH-treated group.
    3 context sentences
    Summary · context
    18-month, randomized, double-blind, placebo-controlled, parallel-group study.
    Summary · context
    2532 postmenopausal women with low bone mineral density at the hip or lumbar spine.
    Summary · context
    Women received 100 mug of recombinant human PTH or placebo daily by subcutaneous injection.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In osteoporotic women, PTH increased hip BMD by 2.1% versus placebo (CI 1.7% to 2.5%).

    In plain wordsIn osteoporotic women, PTH increased hip bone density compared with placebo.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    IncreaseHip BMD
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    100 mug daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Hip BMD difference versus placebo
    2.1%
    PTH vs placebo, hip
    CI of hip BMD difference
    1.7 to 2.5%
    PTH vs placebo, hip

    Source sentences

    Summary
    Compared with placebo, mean bone mineral density increased at the spine by 6.9% (CI, 6.4% to 7.4%) and at the hip by 2.1% (CI, 1.7% to 2.5%) but decreased at the forearm in the PTH-treated group.
    3 context sentences
    Summary · context
    18-month, randomized, double-blind, placebo-controlled, parallel-group study.
    Summary · context
    2532 postmenopausal women with low bone mineral density at the hip or lumbar spine.
    Summary · context
    Women received 100 mug of recombinant human PTH or placebo daily by subcutaneous injection.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In osteoporotic women, PTH decreased forearm BMD compared with placebo.

    In plain wordsIn osteoporotic women, PTH decreased forearm bone density compared with placebo.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    DecreaseForearm BMD
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    100 mug daily · subcutaneous · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    Compared with placebo, mean bone mineral density increased at the spine by 6.9% (CI, 6.4% to 7.4%) and at the hip by 2.1% (CI, 1.7% to 2.5%) but decreased at the forearm in the PTH-treated group.
    3 context sentences
    Summary · context
    18-month, randomized, double-blind, placebo-controlled, parallel-group study.
    Summary · context
    2532 postmenopausal women with low bone mineral density at the hip or lumbar spine.
    Summary · context
    Women received 100 mug of recombinant human PTH or placebo daily by subcutaneous injection.
  7. 07HumanRandomized controlled trialSafety outcome

    In osteoporotic women, PTH increased the percentage with hypercalciuria by 24% versus placebo (CI 20% to 27%).

    In plain wordsIn osteoporotic women, hypercalciuria occurred more often with PTH than with placebo.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    IncreaseHypercalciuria
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Adverse events · Kidney and urinary
    Studied dose
    100 mug daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Increase in participants with hypercalciuria
    24%
    PTH vs placebo
    CI of increase in hypercalciuria
    20 to 27%
    PTH vs placebo

    Source sentences

    Summary
    Parathyroid hormone treatment increased the percentage of participants with hypercalciuria, hypercalcemia, and nausea by 24% (CI, 20% to 27%), 23% (CI, 21% to 26%), and 14% (CI, 11% to 16%), respectively, compared with placebo.
    3 context sentences
    Summary · context
    18-month, randomized, double-blind, placebo-controlled, parallel-group study.
    Summary · context
    2532 postmenopausal women with low bone mineral density at the hip or lumbar spine.
    Summary · context
    Women received 100 mug of recombinant human PTH or placebo daily by subcutaneous injection.
  8. 08HumanRandomized controlled trialSafety outcome

    In osteoporotic women, PTH increased the percentage with hypercalcemia by 23% versus placebo (CI 21% to 26%).

    In plain wordsIn osteoporotic women, high blood calcium occurred more often with PTH than with placebo.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    IncreaseHypercalcemia
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    100 mug daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Increase in participants with hypercalcemia
    23%
    PTH vs placebo
    CI of increase in hypercalcemia
    21 to 26%
    PTH vs placebo

    Source sentences

    Summary
    Parathyroid hormone treatment increased the percentage of participants with hypercalciuria, hypercalcemia, and nausea by 24% (CI, 20% to 27%), 23% (CI, 21% to 26%), and 14% (CI, 11% to 16%), respectively, compared with placebo.
    3 context sentences
    Summary · context
    18-month, randomized, double-blind, placebo-controlled, parallel-group study.
    Summary · context
    2532 postmenopausal women with low bone mineral density at the hip or lumbar spine.
    Summary · context
    Women received 100 mug of recombinant human PTH or placebo daily by subcutaneous injection.
  9. 09HumanRandomized controlled trialSafety outcome

    In osteoporotic women, PTH increased the percentage with nausea by 14% versus placebo (CI 11% to 16%).

    In plain wordsIn osteoporotic women, nausea occurred more often with PTH than with placebo.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    IncreaseNausea
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    100 mug daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Increase in participants with nausea
    14%
    PTH vs placebo
    CI of increase in nausea
    11 to 16%
    PTH vs placebo

    Source sentences

    Summary
    Parathyroid hormone treatment increased the percentage of participants with hypercalciuria, hypercalcemia, and nausea by 24% (CI, 20% to 27%), 23% (CI, 21% to 26%), and 14% (CI, 11% to 16%), respectively, compared with placebo.
    3 context sentences
    Summary · context
    18-month, randomized, double-blind, placebo-controlled, parallel-group study.
    Summary · context
    2532 postmenopausal women with low bone mineral density at the hip or lumbar spine.
    Summary · context
    Women received 100 mug of recombinant human PTH or placebo daily by subcutaneous injection.

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 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT00172081

TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis

Shiren = 2,53227 Apr 2000 to 7 Nov 2003

Osteoporosis

Trial pageClinicalTrials.govUpdated 14 May 2021

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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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