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Study · Randomized controlled trial · 2013

13 results

Combination therapy with risedronate and teriparatide in male osteoporosis.

Walker MD, Cusano NE, Sliney J Jr, Romano M, Zhang C, McMahon DJ, Bilezikian JP

Endocrine26 Oct 2012Cited by 63 (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 study13

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In men with low BMD, lumbar spine BMD increases did not differ between teriparatide and risedronate at 18 months.

    In plain wordsIn men with low bone density, spine density gains did not differ between teriparatide and risedronate.

    Outcome
    No significant changeLumbar spine BMD versus risedronate
    Study

    n: not reported in source

    Comparator
    Risedronate monotherapy
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · subcutaneous · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    All therapies increased LS BMD as compared with baseline (p < 0.05), but there were no between-group differences at 18 months.
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In men with low BMD, adding teriparatide to risedronate did not significantly change lumbar BMD compared with risedronate alone.

    In plain wordsIn men with low bone density, adding teriparatide did not significantly change spine density compared with risedronate alone.

    Outcome
    No significant changeLumbar spine BMD combination versus risedronate
    Study

    n: not reported in source

    Comparator
    Risedronate monotherapy
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · subcutaneous · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    All therapies increased LS BMD as compared with baseline (p < 0.05), but there were no between-group differences at 18 months.
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In men with low BMD, adding teriparatide to risedronate increased total hip BMD more than risedronate alone.

    In plain wordsIn men with low bone density, adding teriparatide increased hip density more than risedronate alone.

    Outcome
    IncreaseTotal hip BMD combination versus risedronate
    Study

    n: not reported in source

    Comparator
    Risedronate monotherapy
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Total hip BMD percentage change
    3.86%
    combination group, mean (SEM 1.1)
    Total hip BMD percentage change
    0.82%
    risedronate alone, mean (SEM 0.95)

    Source sentences

    Summary
    Total hip (TH) BMD increased to a greater extent in the combination group (mean ± SEM, 3.86 ± 1.1 %) versus teriparatide (0.29 ± 0.95 %) or risedronate (0.82 ± 0.95 %; p < 0.05 for both).
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In men with low BMD, adding teriparatide to risedronate increased femoral neck BMD more than risedronate alone.

    In plain wordsIn men with low bone density, adding teriparatide increased femoral neck density more than risedronate alone.

    Outcome
    IncreaseFemoral neck BMD combination versus risedronate
    Study

    n: not reported in source

    Comparator
    Risedronate monotherapy
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Femoral neck BMD percentage change
    8.45%
    combination group, mean (SEM 1.8)
    Femoral neck BMD percentage change
    0.5%
    risedronate alone, mean (SEM 1.7)

    Source sentences

    Summary
    Femoral neck (FN) BMD also increased more in the combination group (8.45 ± 1.8 %) versus risedronate (0.50 ± 1.7 %; p = 0.002), but was not different from teriparatide alone.
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In men with low BMD, P1NP increased rapidly in the teriparatide-alone arm, and the combination arm mirrored this increase.

    In plain wordsIn men with low bone density, P1NP increased during teriparatide treatment compared with baseline.

    Outcome
    IncreaseMonotherapy P1NP
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · subcutaneous · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    In the combination group, P1NP and CTX increased rapidly, mirroring the teriparatide-alone arm.
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In men with low BMD, CTX increased rapidly in the teriparatide-alone arm, and the combination arm mirrored this increase.

    In plain wordsIn men with low bone density, CTX increased during teriparatide treatment compared with baseline.

    Outcome
    IncreaseMonotherapy CTX
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · subcutaneous · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    In the combination group, P1NP and CTX increased rapidly, mirroring the teriparatide-alone arm.
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.
  7. 07HumanRandomized controlled trialSafety outcome

    In men with low BMD, adverse events did not differ between teriparatide and risedronate.

    In plain wordsIn men with low bone density, adverse events did not differ between teriparatide and risedronate.

    Outcome
    No significant changeAdverse events versus risedronate
    Study

    n: not reported in source

    Comparator
    Risedronate monotherapy
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 μg daily · subcutaneous · 18 monthsAs given in this study (human).

    Source sentences

    Summary
    There were no between-group differences in adverse events.
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.

Studies that did not test the peptide alone6

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. 08HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In men with low BMD, lumbar spine BMD increased from baseline in all groups, including risedronate alone, teriparatide alone, and their combination.

    In plain wordsIn men with low bone density, spine density increased from baseline in all groups, including both individual drugs and their combination.

    Outcome
    IncreaseLumbar spine BMD change across all therapies
    Study

    n = 29

    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    All therapies increased LS BMD as compared with baseline (p < 0.05), but there were no between-group differences at 18 months.
    2 context sentences
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.
    Summary · context
    The primary endpoint was percentage change in lumbar spine (LS) BMD at 18 months.

    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).

  2. 09HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In men with low BMD, lumbar spine BMD increases did not differ between risedronate plus teriparatide and teriparatide alone.

    In plain wordsIn men with low bone density, spine density gains did not differ between risedronate plus teriparatide and teriparatide alone.

    Outcome
    No significant changeLumbar spine BMD combination versus teriparatide
    Study

    n: not reported in source

    Comparator
    Teriparatide monotherapy
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    All therapies increased LS BMD as compared with baseline (p < 0.05), but there were no between-group differences at 18 months.
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.

    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).

  3. 10HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In men with low BMD, risedronate plus teriparatide increased total hip BMD more than teriparatide alone.

    In plain wordsIn men with low bone density, risedronate plus teriparatide increased hip density more than teriparatide alone.

    Outcome
    IncreaseTotal hip BMD combination versus teriparatide
    Study

    n: not reported in source

    Comparator
    Teriparatide monotherapy
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Total hip BMD percentage change
    3.86%
    combination group, mean (SEM 1.1)
    Total hip BMD percentage change
    0.29%
    teriparatide alone, mean (SEM 0.95)

    Source sentences

    Summary
    Total hip (TH) BMD increased to a greater extent in the combination group (mean ± SEM, 3.86 ± 1.1 %) versus teriparatide (0.29 ± 0.95 %) or risedronate (0.82 ± 0.95 %; p < 0.05 for both).
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.

    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).

  4. 11HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In men with low BMD, femoral neck BMD gains did not differ between risedronate plus teriparatide and teriparatide alone.

    In plain wordsIn men with low bone density, femoral neck density gains did not differ between risedronate plus teriparatide and teriparatide alone.

    Outcome
    No significant changeFemoral neck BMD combination versus teriparatide
    Study

    n: not reported in source

    Comparator
    Teriparatide monotherapy
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Femoral neck BMD percentage change
    8.45%
    combination group, mean (SEM 1.8)

    Source sentences

    Summary
    Femoral neck (FN) BMD also increased more in the combination group (8.45 ± 1.8 %) versus risedronate (0.50 ± 1.7 %; p = 0.002), but was not different from teriparatide alone.
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.

    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).

  5. 12HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In men with low BMD, P1NP increased rapidly with risedronate plus teriparatide, mirroring teriparatide alone.

    In plain wordsIn men with low bone density, P1NP increased with risedronate plus teriparatide, with a pattern similar to teriparatide alone.

    Outcome
    IncreaseCombination P1NP
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    In the combination group, P1NP and CTX increased rapidly, mirroring the teriparatide-alone arm.
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.

    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).

  6. 13HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In men with low BMD, CTX increased rapidly with risedronate plus teriparatide, mirroring teriparatide alone.

    In plain wordsIn men with low bone density, CTX increased with risedronate plus teriparatide, with a pattern similar to teriparatide alone.

    Outcome
    IncreaseCombination CTX
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    In the combination group, P1NP and CTX increased rapidly, mirroring the teriparatide-alone arm.
    1 context sentence
    Summary · context
    This was a randomized, double-blinded study of risedronate (35 mg weekly plus placebo injection), teriparatide (20 μg subcutaneously daily plus placebo tablet), or both risedronate plus teriparatide (combination) for 18 months in 29 men with low BMD.

    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 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01611571

Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis

Columbia Universityn = 31Dec 2003 to Nov 2011

Osteoporosis

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.

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