Evaluation of the fracture prevention effects of teriparatide and alendronate in patients with frailty: a sub-analysis of the Japanese osteoporosis intervention trial-05.

Hosoi T, Yunoki M, Tanaka S, Hagino H, Mori S, Soen S, Ogawa S

Journal of bone and mineral metabolism27 May 2025Cited by 3 (Europe PMC)

PMID40425867PMCIDPMC12279556DOI10.1007/s00774-025-01610-1PepBankPUB-40425867

Summary

IntroductionThe fracture prevention effects of teriparatide (TPTD) and alendronate (ALN) were evaluated in frail patients using data from the JOINT-05 trial. In addition, predictors of adherence-related treatment discontinuation were evaluated for TPTD and ALN.Materials and methodsJapanese women aged ≥ 75 years with primary osteoporosis and high fracture risk were randomized to either sequential therapy (TPTD for 72 weeks followed by ALN for 48 weeks) or ALN monotherapy for 120 weeks. Cognitive frailty was defined as an MMSE score ≤ 27, and physical frailty as requiring support or nursing care. Vertebral, non-vertebral, and all fractures were assessed. Adherence-related discontinuations were identified, and baseline predictors were analyzed using multiple regression to calculate odds ratios.ResultsA total of 514 patients with cognitive frailty (254 with TPTD, 260 with ALN) and 204 patients with physical frailty (109 with TPTD, 95 with ALN) were identified. In patients with cognitive frailty, vertebral fracture incidence tended to be lower with TPTD (rate ratio 0.72), but not significantly. In patients with physical frailty, the incidence was significantly lower with TPTD (rate ratio 0.50, p < 0.01). Dyslipidemia and serum calcium levels were significant predictors of TPTD discontinuation, whereas cognitive impairment and dyslipidemia were predictors for ALN discontinuation.ConclusionIn patients with physical frailty, TPTD reduced vertebral fractures significantly more than ALN. However, in cases with cognitive impairment, the results of the JOINT-05 study may not necessarily apply. Assessing the presence of dyslipidemia and cognitive decline may be useful for predicting adherence-related discontinuation.Trial registrationjRCTs031180235 and UMIN000015573, March 12, 2019.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone4

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).

01HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome
In women with cognitive frailty, sequential teriparatide and alendronate did not significantly reduce vertebral fractures versus alendronate alone.
In plain wordsIn women with cognitive frailty, sequential teriparatide and alendronate did not significantly reduce vertebral fractures versus alendronate alone.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeVertebral fractures in cognitive frailty
Study
n = 514
Comparator
Alendronate monotherapy
Outcome group
Bone and joint · Musculoskeletal
Measurements
Rate ratio
0.72 ratio
cognitive frailty
Source sentences
Summary
In patients with cognitive frailty, vertebral fracture incidence tended to be lower with TPTD (rate ratio 0.72), but not significantly.
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese women aged ≥ 75 years with primary osteoporosis and high fracture risk were randomized to either sequential therapy (TPTD for 72 weeks followed by ALN for 48 weeks) or ALN monotherapy for 120 weeks.
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).
Show in the study text Report a problemFND-4042586701
02HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome
In women with physical frailty, sequential teriparatide and alendronate reduced vertebral fractures versus alendronate alone.
In plain wordsIn women with physical frailty, sequential teriparatide and alendronate reduced vertebral fractures versus alendronate alone.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseVertebral fractures in physical frailty
Study
n = 204
Comparator
Alendronate monotherapy
Outcome group
Bone and joint · Musculoskeletal
Measurements
Rate ratio
0.5 ratio
physical frailty
Source sentences
Summary
In patients with physical frailty, the incidence was significantly lower with TPTD (rate ratio 0.50, p < 0.01).
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese women aged ≥ 75 years with primary osteoporosis and high fracture risk were randomized to either sequential therapy (TPTD for 72 weeks followed by ALN for 48 weeks) or ALN monotherapy for 120 weeks.
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).
Show in the study text Report a problemFND-4042586702
03HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyOther
In older women with osteoporosis, dyslipidemia predicted adherence-related teriparatide discontinuation.
In plain wordsIn older women with osteoporosis, dyslipidemia was linked to teriparatide discontinuation.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableDyslipidemia as discontinuation predictor
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Source sentences
Summary
Dyslipidemia and serum calcium levels were significant predictors of TPTD discontinuation, whereas cognitive impairment and dyslipidemia were predictors for ALN discontinuation.
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese women aged ≥ 75 years with primary osteoporosis and high fracture risk were randomized to either sequential therapy (TPTD for 72 weeks followed by ALN for 48 weeks) or ALN monotherapy for 120 weeks.
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).
Show in the study text Report a problemFND-4042586703
04HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyOther
In older women with osteoporosis, serum calcium levels predicted adherence-related teriparatide discontinuation.
In plain wordsIn older women with osteoporosis, serum calcium levels were linked to teriparatide discontinuation.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableSerum calcium as discontinuation predictor
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Source sentences
Summary
Dyslipidemia and serum calcium levels were significant predictors of TPTD discontinuation, whereas cognitive impairment and dyslipidemia were predictors for ALN discontinuation.
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese women aged ≥ 75 years with primary osteoporosis and high fracture risk were randomized to either sequential therapy (TPTD for 72 weeks followed by ALN for 48 weeks) or ALN monotherapy for 120 weeks.
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).
Show in the study text Report a problemFND-4042586704

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

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
22 Oct 2026, 02:26 UTC
Study results updated
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.