Randomized crossover comparison of two teriparatide self-injection regimens for primary osteoporosis: final report of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06).

Tanaka S, Uemura Y, Tanaka S, Takeuchi Y, Endo N, Takada J, Ikeda S, Iwamoto J, Okimoto N, Soen S

Journal of bone and mineral metabolism3 Sept 2025

PMID40900219PMCIDPMC12701856DOI10.1007/s00774-025-01631-wPepBankPUB-40900219

Summary

IntroductionAlthough bone anabolic agents such as teriparatide are effective for osteoporosis, satisfaction and adherence may vary by regimen. This multicenter study assessed long-term satisfaction, persistence, efficacy, and safety in postmenopausal women with primary osteoporosis treated with alternating daily and twice-weekly teriparatide over 52 weeks, followed by a final free-choice treatment period.Materials and methodsIn a randomized, open-label, crossover study, 358 postmenopausal women at high risk for fracture were assigned to receive once-daily (20 µg) or twice-weekly (28.2 µg) subcutaneous teriparatide for 26 weeks, then crossed over to the alternative regimen for another 26 weeks. Afterwards, 233 patients entered a 52-week free-choice period under their preferred regimen.ResultsAmong the 233 patients entering the free-choice period, 162 chose twice-weekly and 71 chose daily teriparatide. Persistence at 104 weeks was 90.1% for twice-weekly and 88.7% for daily groups (p = 0.749). Overall and treatment satisfaction between groups did not differ significantly at 104 weeks (p > 0.05). Fracture incidence was low and similar (2.8% vs. 1.2%, p = 0.758). Patients in both groups showed significant increases in bone mineral density at L2-L4 and the femoral neck (p < 0.05). Adverse events were infrequent and non-severe.ConclusionsPatient satisfaction and efficacy were maintained with both teriparatide regimens over 104 weeks, and persistence improved during the patient-choice phase. Supporting patient preference may improve adherence to osteoporosis medications.Clinical trial registrationJapan Registry of Clinical Trials ID: jRCTs031210187.

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

Results from this study8

3 results from studies that gave the peptide. 3 results from people.

01HumanNon-randomized trialEfficacy outcome
In women with osteoporosis, L2-L4 BMD increased significantly in both teriparatide regimen groups.
In plain wordsIn women with osteoporosis, lower spine bone density increased from baseline in both teriparatide regimen groups.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseL2-L4 BMD
Study
n = 233
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 µg once daily or 28.2 µg twice weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
Patients in both groups showed significant increases in bone mineral density at L2-L4 and the femoral neck (p < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
In a randomized, open-label, crossover study, 358 postmenopausal women at high risk for fracture were assigned to receive once-daily (20 µg) or twice-weekly (28.2 µg) subcutaneous teriparatide for 26 weeks, then crossed over to the alternative regimen for another 26 weeks.
Summary · context
Afterwards, 233 patients entered a 52-week free-choice period under their preferred regimen.
Show in the study text Report a problemFND-4090021906
02HumanNon-randomized trialEfficacy outcome
In women with osteoporosis, femoral neck BMD increased significantly in both teriparatide regimen groups.
In plain wordsIn women with osteoporosis, femoral neck bone density increased from baseline in both teriparatide regimen groups.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseFemoral neck BMD
Study
n = 233
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 µg once daily or 28.2 µg twice weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
Patients in both groups showed significant increases in bone mineral density at L2-L4 and the femoral neck (p < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
In a randomized, open-label, crossover study, 358 postmenopausal women at high risk for fracture were assigned to receive once-daily (20 µg) or twice-weekly (28.2 µg) subcutaneous teriparatide for 26 weeks, then crossed over to the alternative regimen for another 26 weeks.
Summary · context
Afterwards, 233 patients entered a 52-week free-choice period under their preferred regimen.
Show in the study text Report a problemFND-4090021907
03HumanNon-randomized trialSafety outcome
In women with osteoporosis receiving teriparatide regimens, adverse events were infrequent and non-severe.
In plain wordsIn women with osteoporosis receiving teriparatide regimens, adverse events were infrequent and not severe.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableAdverse events
Study
n = 233
Outcome group
Adverse events · Whole body
Studied dose
20 µg once daily or 28.2 µg twice weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
Adverse events were infrequent and non-severe.
2 context sentences(design, population, supporting numbers)
Summary · context
In a randomized, open-label, crossover study, 358 postmenopausal women at high risk for fracture were assigned to receive once-daily (20 µg) or twice-weekly (28.2 µg) subcutaneous teriparatide for 26 weeks, then crossed over to the alternative regimen for another 26 weeks.
Summary · context
Afterwards, 233 patients entered a 52-week free-choice period under their preferred regimen.
Show in the study text Report a problemFND-4090021908

Studies that did not test the peptide alone5

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).

04HumanNot a test of Teriparatide (PTH 1-34) aloneNon-randomized trialOther
Among women entering the free-choice period, 162 chose twice-weekly and 71 chose daily teriparatide.
In plain wordsAmong women entering the choice period, 162 chose twice-weekly and 71 chose daily teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableRegimen choice
Study
n = 233
Outcome group
Bone and joint · Musculoskeletal
Measurements
Patients choosing regimen
162 patients
twice-weekly
Patients choosing regimen
71 patients
daily
Source sentences
Summary
Among the 233 patients entering the free-choice period, 162 chose twice-weekly and 71 chose daily teriparatide.
2 context sentences(design, population, supporting numbers)
Summary · context
In a randomized, open-label, crossover study, 358 postmenopausal women at high risk for fracture were assigned to receive once-daily (20 µg) or twice-weekly (28.2 µg) subcutaneous teriparatide for 26 weeks, then crossed over to the alternative regimen for another 26 weeks.
Summary · context
Afterwards, 233 patients entered a 52-week free-choice period under their preferred regimen.
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-4090021901
05HumanNot a test of Teriparatide (PTH 1-34) aloneNon-randomized trialEfficacy outcome
In women with osteoporosis, persistence did not differ between twice-weekly and daily teriparatide at 104 weeks.
In plain wordsIn women with osteoporosis, persistence did not differ between twice-weekly and daily teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changePersistence at 104 weeks
Study
n = 233
Comparator
Daily teriparatide
Outcome group
Bone and joint · Musculoskeletal
Measurements
Persistence
90.1%
twice-weekly
Persistence
88.7%
daily
Source sentences
Summary
Persistence at 104 weeks was 90.1% for twice-weekly and 88.7% for daily groups (p = 0.749).
2 context sentences(design, population, supporting numbers)
Summary · context
In a randomized, open-label, crossover study, 358 postmenopausal women at high risk for fracture were assigned to receive once-daily (20 µg) or twice-weekly (28.2 µg) subcutaneous teriparatide for 26 weeks, then crossed over to the alternative regimen for another 26 weeks.
Summary · context
Afterwards, 233 patients entered a 52-week free-choice period under their preferred regimen.
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-4090021902
06HumanNot a test of Teriparatide (PTH 1-34) aloneNon-randomized trialEfficacy outcome
In women with osteoporosis, overall satisfaction did not differ between twice-weekly and daily teriparatide at 104 weeks.
In plain wordsIn women with osteoporosis, overall satisfaction did not differ between twice-weekly and daily teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeOverall satisfaction
Study
n = 233
Comparator
Daily teriparatide
Outcome group
Bone and joint · Musculoskeletal
Source sentences
Summary
Overall and treatment satisfaction between groups did not differ significantly at 104 weeks (p > 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
In a randomized, open-label, crossover study, 358 postmenopausal women at high risk for fracture were assigned to receive once-daily (20 µg) or twice-weekly (28.2 µg) subcutaneous teriparatide for 26 weeks, then crossed over to the alternative regimen for another 26 weeks.
Summary · context
Afterwards, 233 patients entered a 52-week free-choice period under their preferred regimen.
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-4090021903
07HumanNot a test of Teriparatide (PTH 1-34) aloneNon-randomized trialEfficacy outcome
In women with osteoporosis, treatment satisfaction did not differ between twice-weekly and daily teriparatide at 104 weeks.
In plain wordsIn women with osteoporosis, treatment satisfaction did not differ between twice-weekly and daily teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeTreatment satisfaction
Study
n = 233
Comparator
Daily teriparatide
Outcome group
Bone and joint · Musculoskeletal
Source sentences
Summary
Overall and treatment satisfaction between groups did not differ significantly at 104 weeks (p > 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
In a randomized, open-label, crossover study, 358 postmenopausal women at high risk for fracture were assigned to receive once-daily (20 µg) or twice-weekly (28.2 µg) subcutaneous teriparatide for 26 weeks, then crossed over to the alternative regimen for another 26 weeks.
Summary · context
Afterwards, 233 patients entered a 52-week free-choice period under their preferred regimen.
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-4090021904
08HumanNot a test of Teriparatide (PTH 1-34) aloneNon-randomized trialEfficacy outcome
In women with osteoporosis, fracture incidence was low and similar between teriparatide regimen groups.
In plain wordsIn women with osteoporosis, fracture incidence was low and similar between teriparatide regimen groups.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeFracture incidence
Study
n = 233
Comparator
Alternative teriparatide regimen
Outcome group
Bone and joint · Musculoskeletal
Measurements
Fracture incidence
2.8%
first-listed group of 2.8% vs 1.2%
Fracture incidence
1.2%
second-listed group of 2.8% vs 1.2%
Source sentences
Summary
Fracture incidence was low and similar (2.8% vs. 1.2%, p = 0.758).
2 context sentences(design, population, supporting numbers)
Summary · context
In a randomized, open-label, crossover study, 358 postmenopausal women at high risk for fracture were assigned to receive once-daily (20 µg) or twice-weekly (28.2 µg) subcutaneous teriparatide for 26 weeks, then crossed over to the alternative regimen for another 26 weeks.
Summary · context
Afterwards, 233 patients entered a 52-week free-choice period under their preferred regimen.
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-4090021905

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

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