Does Teriparatide work?
Yes, in a large controlled trial of 1,637 women.
The Fracture Prevention Trial randomized 1,637 postmenopausal women with prior vertebral fractures to teriparatide or placebo and showed fewer new vertebral and nonvertebral fractures over a median of 21 months. The approved use matches the trial population, and the label has since been expanded on further human data, so the grade is A. 12
The Fracture Prevention Trial appeared in the New England Journal of Medicine in 2001. It randomized 1,637 postmenopausal women who already had at least one spine fracture. They got one of two teriparatide doses or placebo. Researchers followed them for a median of 21 months. New spine fractures occurred in 14 percent of the placebo group. On the dose later approved, 5 percent had them. That is a 65 percent relative drop. New nonvertebral fragility fractures fell from 6 percent to 3 percent. Spine bone density rose 9 percentage points more than with placebo. 1
The trial was stopped early. Rats given high doses for most of their lives developed osteosarcoma. So follow-up is shorter than planned. Later claims-database studies linked to cancer registries found no extra osteosarcoma in people treated with teriparatide. The FDA cited them when it revised the label in 2020. 2
Evidence checklist
- Randomised controlled trial Fracture Prevention Trial, placebo-controlled
- Human study over 100 people 1,637 postmenopausal women
- More than one research group Trial plus two decades of label data
- Clinical outcomes, not surrogate markers New spine and non-spine fractures fell
- Human safety data beyond case reports Osteosarcoma warning stayed; no human signal
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More on Teriparatide
Citations
- Neer 2001, NEJM: Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis doi.org
- Eli Lilly: Forteo (teriparatide injection) prescribing information uspl.lilly.com
Reference information only, not medical advice. Drawn from the Teriparatide article, fact-checked against the cited sources. No dosing anywhere on this site.