Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis

This is a randomized, controlled, and exploratory study designed to evaluate the chronotherapeutic effects of teriparatide administration in postmenopausal osteoporosis. Twenty-eight participants (age 60-70 years, lumbar spine T-score ≤-3.0) will undergo 1:1 randomization to receive 20 µg/day teriparatide subcutaneously at either 08:00 or 20:00 for 12 weeks. Standardized supplementation with calcium (1,000-1,500 mg/day) and cholecalciferol (800-1,200 IU/day) will be maintained. Primary endpoints are between-group differences in serum CTX and P1NP profiles, quantified at baseline, 4-week interim, and 12-week endpoint. The secondary outcomes will assess safety during the trial.

NCT Number	NCT06951776
Lead Sponsor	Peking University Third Hospital
Conditions	Circadian Rhythm Disorders, Osteoporosis
Enrollment	28 participants
Start Date	2025-05-01
Primary Completion	2025-12-30 (estimated)
Study Completion	2025-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-04-30