Treatment of postmenopausal women with osteoporosis with PTH(1-84) for 36 months: treatment extension study.

Zanchetta JR, Bogado CE, Cisari C, Aslanidis S, Greisen H, Fox J, Lems W

Current medical research and opinion5 Oct 2010Cited by 12 (Europe PMC)

PMID20923256DOI10.1185/03007995.2010.524121PepBankPUB-20923256

Publisher page PubMedAsk about this study

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.

01HumanNon-randomized trialEfficacy outcome
In postmenopausal women with osteoporosis, PTH(1-84) increased lumbar spine BMD by 8.5% above baseline at 36 months.
In plain wordsIn women with osteoporosis, spine bone density increased by 8.5% from baseline after 36 months of PTH.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseLumbar spine BMD at 36 months
Study
n: not reported in source
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 µg once daily · 36 monthsAs given in this study (human).
Measurements
Lumbar spine BMD change from baseline
8.5%
at 36 months of PTH(1-84) treatment; p<0.001
Source sentences
Summary
Lumbar spine BMD increased by 8.5% above baseline (p < 0.001) at 36 months of PTH(1-84) treatment, remaining stable during the last 12 months of treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
The safety and efficacy of 36 months of once-daily dosing with 100 µg PTH(1-84) in postmenopausal women with osteoporosis were assessed.
Summary · context
There was no placebo group for BMD comparisons.
Report a problemFND-2092325601
02HumanNon-randomized trialEfficacy outcome
In postmenopausal women with osteoporosis, lumbar spine BMD remained stable during the last 12 months of PTH(1-84) treatment.
In plain wordsIn women with osteoporosis, spine bone density remained stable during the last 12 months of PTH treatment.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Direction not reportedLumbar spine BMD during last 12 months
Study
n: not reported in source
Comparator
Start of last 12 months
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 µg once daily · 36 monthsAs given in this study (human).
Source sentences
Summary
Lumbar spine BMD increased by 8.5% above baseline (p < 0.001) at 36 months of PTH(1-84) treatment, remaining stable during the last 12 months of treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
The safety and efficacy of 36 months of once-daily dosing with 100 µg PTH(1-84) in postmenopausal women with osteoporosis were assessed.
Summary · context
There was no placebo group for BMD comparisons.
Report a problemFND-2092325602
03HumanNon-randomized trialEfficacy outcome
In postmenopausal women with osteoporosis, total hip BMD increased by 3.2% above baseline at 36 months of PTH(1-84).
In plain wordsIn women with osteoporosis, hip bone density increased by 3.2% from baseline after 36 months of PTH.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseTotal hip BMD at 36 months
Study
n: not reported in source
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 µg once daily · 36 monthsAs given in this study (human).
Measurements
Total hip BMD increase above baseline
3.2%
PTH(1-84) 100 µg daily, 36 months
Source sentences
Summary
Increases in total hip and femoral neck BMD occurred more slowly, reaching 3.2% and 3.4%, respectively above baseline at 36 months (p < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
The safety and efficacy of 36 months of once-daily dosing with 100 µg PTH(1-84) in postmenopausal women with osteoporosis were assessed.
Summary · context
There was no placebo group for BMD comparisons.
Report a problemFND-2092325603
04HumanNon-randomized trialEfficacy outcome
In postmenopausal women with osteoporosis, femoral neck BMD increased by 3.4% above baseline at 36 months of PTH(1-84).
In plain wordsIn women with osteoporosis, femoral neck bone density increased by 3.4% from baseline after 36 months of PTH.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseFemoral neck BMD at 36 months
Study
n: not reported in source
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 µg once daily · 36 monthsAs given in this study (human).
Measurements
Femoral neck BMD increase above baseline
3.4%
PTH(1-84) 100 µg daily, 36 months
Source sentences
Summary
Increases in total hip and femoral neck BMD occurred more slowly, reaching 3.2% and 3.4%, respectively above baseline at 36 months (p < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
The safety and efficacy of 36 months of once-daily dosing with 100 µg PTH(1-84) in postmenopausal women with osteoporosis were assessed.
Summary · context
There was no placebo group for BMD comparisons.
Report a problemFND-2092325604
05HumanNon-randomized trialEfficacy outcome
In postmenopausal women with osteoporosis, total hip BMD showed no plateau during PTH(1-84) treatment.
In plain wordsIn women with osteoporosis, hip bone density showed no plateau during PTH treatment.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseTotal hip BMD trajectory
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 µg once daily · 36 monthsAs given in this study (human).
Source sentences
Summary
The total hip BMD showed no signs of reaching a limiting value although the femoral neck plateaued from months 24 to 36.
2 context sentences(design, population, supporting numbers)
Summary · context
The safety and efficacy of 36 months of once-daily dosing with 100 µg PTH(1-84) in postmenopausal women with osteoporosis were assessed.
Summary · context
There was no placebo group for BMD comparisons.
Report a problemFND-2092325605
06HumanNon-randomized trialEfficacy outcome
In postmenopausal women with osteoporosis, femoral neck BMD plateaued from months 24 to 36 of PTH(1-84).
In plain wordsIn women with osteoporosis, femoral neck bone density plateaued from months 24 to 36 of PTH.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Direction not reportedFemoral neck BMD months 24 to 36
Study
n: not reported in source
Comparator
Month 24
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 µg once daily · 36 monthsAs given in this study (human).
Source sentences
Summary
The total hip BMD showed no signs of reaching a limiting value although the femoral neck plateaued from months 24 to 36.
2 context sentences(design, population, supporting numbers)
Summary · context
The safety and efficacy of 36 months of once-daily dosing with 100 µg PTH(1-84) in postmenopausal women with osteoporosis were assessed.
Summary · context
There was no placebo group for BMD comparisons.
Report a problemFND-2092325606
07HumanNon-randomized trialEfficacy outcome
In osteoporotic women, seven patients had vertebral fractures before PTH(1-84), versus a single worsened fracture in the first 6 months and none from months 6 to 36.
In plain wordsIn women with osteoporosis, vertebral fractures declined after PTH began compared with the previous placebo phase.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
DecreaseVertebral fractures
Study
n: not reported in source
Comparator
Pretreatment placebo phase
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 µg once daily · 36 monthsAs given in this study (human).
Measurements
Patients with vertebral fractures
7 patients
placebo phase of TOP trial, before extension
Worsened vertebral fractures
1 fractures
first 6 months of PTH(1-84)
Source sentences
Summary
Seven patients had vertebral fractures during the placebo phase of the TOP trial and before entering the extension study, but this rate decreased with the introduction of PTH(1-84) therapy, resulting in a single worsened vertebral fracture in the first 6 months and no further vertebral fractures from months 6 to 36.
2 context sentences(design, population, supporting numbers)
Summary · context
The safety and efficacy of 36 months of once-daily dosing with 100 µg PTH(1-84) in postmenopausal women with osteoporosis were assessed.
Summary · context
There was no placebo group for BMD comparisons.
Report a problemFND-2092325607
08HumanNon-randomized trialSafety outcome
In postmenopausal women with osteoporosis, PTH(1-84) was well tolerated over 36 months.
In plain wordsIn women with osteoporosis, PTH was well tolerated over 36 months.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableTreatment tolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
100 µg once daily · 36 monthsAs given in this study (human).
Source sentences
Summary
Treatment over 36 months with PTH(1-84) was well-tolerated and iliac crest biopsies showed no adverse effects on bone.
2 context sentences(design, population, supporting numbers)
Summary · context
The safety and efficacy of 36 months of once-daily dosing with 100 µg PTH(1-84) in postmenopausal women with osteoporosis were assessed.
Summary · context
There was no placebo group for BMD comparisons.
Report a problemFND-2092325608
09HumanNon-randomized trialSafety outcome
In postmenopausal women receiving PTH(1-84), iliac crest biopsies showed no adverse effects on bone.
In plain wordsIn women receiving PTH, bone biopsies showed no adverse effects on bone.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableAdverse bone biopsy findings
Study
n: not reported in source
Outcome group
Adverse events · Musculoskeletal
Studied dose
100 µg once daily · 36 monthsAs given in this study (human).
Source sentences
Summary
Treatment over 36 months with PTH(1-84) was well-tolerated and iliac crest biopsies showed no adverse effects on bone.
2 context sentences(design, population, supporting numbers)
Summary · context
The safety and efficacy of 36 months of once-daily dosing with 100 µg PTH(1-84) in postmenopausal women with osteoporosis were assessed.
Summary · context
There was no placebo group for BMD comparisons.
Report a problemFND-2092325609

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 3NCT00172120

Open Label Extension

Shiren = 9110 Jan 2005 to 27 Oct 2006

Osteoporosis

Trial page ClinicalTrials.govUpdated 17 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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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