Oral daily PTH(1-34) tablets (EB613) in postmenopausal women with low BMD or osteoporosis: a randomized, placebo-controlled, 6-month, phase 2 study
Authors' conclusion
In contrast to subcutaneous PTH, the oral PTH tablet appears to increase BMD rapidly by the dual mechanism of stimulating formation and inhibiting bone resorption.
Study context
- Population
- Postmenopausal women with low BMD or osteoporosisrandomized
- Participants
- 161 women
- Comparison
- 0.5 mg vs 1.0 mg vs 1.5 mg vs 2.5 mg vs Placebo
Methodological detailsdouble-blind, placebo-controlled, phase 2, dose-ranging
- Double-blind
- Placebo-controlled
- Phase 2
- Dose-ranging
Primary result
As reported in the abstract
Bone formation (P1NP, osteocalcin) and resorption (CTX) markers; BMD · 1, 2, 3 and 6 mo
2.5 mg: serum P1NP and osteocalcin increase within 1 mo (P < .0001); elevated through 3 mo, back to baseline at 6 mo
30%
2.5 mg: serum CTX decline below baseline at 3 mo (P ≤ .02)
16%
2.5 mg: serum CTX decline below baseline at 6 mo (P ≤ .02)
21%
Further findings
| Outcome | Estimate | P value |
|---|---|---|
| Mean BMD increase, 2.5 mg vs placebo · 6 mo2.5 mg vs Placebo | LS BMD increase 2.7 % | P ≤ 0.01 |
| Mean BMD increase, 2.5 mg vs placebo · 6 mo2.5 mg vs Placebo | TH BMD increase 1.8 % | P ≤ 0.01 |
| Mean BMD increase, 2.5 mg vs placebo · 6 mo2.5 mg vs Placebo | FN BMD increase 2.8 % | P ≤ 0.01 |
Safety
- Drug-related serious adverse events
- 0
- Most common adverse events: headache, nausea, dizziness
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Oral daily PTH(1-34) tablets (EB613) in postmenopausal women with low BMD or osteoporosis: a randomized, placebo-controlled, 6-month, phase 2 study. J Bone Miner Res. Published 5 April 2024. doi:10.
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