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Most Teriparatide studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from high-quality meta-analyses and randomised trials published 2001–2024 with a typical study size of 437 participants.
Based on 11 studies · 3 meta-analyses · 4 RCTs · 11,234 total participants
Confidence
High
By outcome
Bone health
Mostly mechanism / observational7 studies
Fracture & skeletal outcomes
Mostly mechanism / observational4 studies
Safety profile
Mostly mechanism / observational4 studies
Steady research
3 studies in the last 5 years · Latest meta-analysis: 2024
200120122024
1RCTn=1,637 · large study2001
New vertebral fractures occurred in 14 percent of the women in the placebo group and in 5 percent... of the women in the 20-microg... parathyroid hormone groups; the respective relative risks... were 0.35 and 0.31.
Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, et al. · N Engl J Med (2001)
Pivotal Fracture Prevention Trial: 1637 postmenopausal women with prior vertebral fractures randomized to PTH(1-34) 20 or 40 microg/day or placebo, median 21 months
New vertebral fractures: 14% placebo vs 5% (20 microg) — relative risk 0.35 (95% CI 0.22-0.55)
New nonvertebral fragility fractures: 6% placebo vs 3% — relative risk ~0.47
2RCTn=1,360 · large study2018
New vertebral fractures occurred in 28 (5.4%) of 680 patients in the teriparatide group and 64 (12.0%) of 680 patients in the risedronate group (risk ratio 0.44, 95% CI 0.29-0.68; p<0.0001).
Head-to-head double-blind, double-dummy RCT of teriparatide 20 microg/day vs risedronate 35 mg/week in 1360 women with severe osteoporosis over 24 months
First osteoporosis trial powered with incident fractures as the primary outcome
New vertebral fractures: 5.4% teriparatide vs 12.0% risedronate (RR 0.44; p<0.0001)
We compared teriparatide with alendronate in 428 women and men with osteoporosis... who had received glucocorticoids for at least 3 months.
Saag KG, Shane E, Boonen S, Marín F, Donley DW, et al. · N Engl J Med (2007)
18-month randomized, double-blind, controlled head-to-head trial in 428 patients with glucocorticoid-induced osteoporosis
Teriparatide 20 microg/day vs alendronate 10 mg/day; primary outcome was change in lumbar-spine BMD
Teriparatide produced greater spine BMD gains than alendronate
4RCTn=437 · medium study2003
Spine bone mineral density... by the end of therapy it was increased by 5.9% (20 microg) and 9.0% (40 microg) above baseline (p < 0.001 vs. placebo for both comparisons).
Orwoll ES, Scheele WH, Paul S, Adami S, Syversen U, Diez-Perez A, et al. · J Bone Miner Res (2003)
RCT in 437 men with osteoporosis randomized to placebo, teriparatide 20 microg, or 40 microg, plus calcium and vitamin D
Spine BMD rose 5.9% (20 microg) and 9.0% (40 microg) above baseline (p<0.001 vs placebo)
Femoral-neck BMD rose 1.5% (20 microg; p=0.029) and 2.9% (40 microg; p<0.001)
5Meta-Analysisn=6,680 · very large study2024
Both teriparatide and denosumab significantly increased bone mineral density compared to bisphosphonates. Additionally, teriparatide was also shown to significantly decrease the risk of fractures.
Li M, Ge Z, Zhang B, Sun L, Wang Z, Zou T, et al. · Arch Osteoporos (2024)
Systematic review and meta-analysis of head-to-head RCTs (6680 patients) in bisphosphonate-naive osteoporosis
Teriparatide significantly increased BMD versus bisphosphonates over treatment cycles >12 months
Teriparatide significantly reduced fracture risk versus bisphosphonates
Recombinant human parathyroid hormone (PTH 1-34) is the only anabolic agent currently approved for the treatment of osteoporosis.
Cosman F · Curr Osteoporos Rep (2005)
Review of PTH anabolic therapy and its place among osteoporosis treatments
PTH stimulates bone formation, in contrast to antiresorptive agents that reduce resorption
Adding a bisphosphonate concurrently to PTH in treatment-naive patients does not add bone benefit; sequential antiresorptive AFTER PTH preserves the gain
11Observationaln=98 · small study2017
The union rate at six months after treatment was 89% in the TPD group and 68% in the BP group.
Iwata A, Kanayama M, Oha F, Hashimoto T, Iwasaki N · BMC Musculoskelet Disord (2017)
Retrospective comparative study in 98 patients with osteoporotic vertebral compression fractures (38 teriparatide vs 60 alendronate)
Teriparatide reduced time-to-union (adjusted hazard ratio 1.86; 95% CI 1.21-2.83)
Six-month union rate 89% (teriparatide) vs 68% (bisphosphonate)