Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis (NCT06951776) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis
28 participantsStarted 2025-05-01
Plain-language summary
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.
Who can participate
Age range60 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Aged 60-70 years (inclusive).
✓. Naturally postmenopausal women with≥5 years since last menses.
✓. DXA-measured BMD T-score≤-3.0 at lumbar spine (L1-L4) and/or total hip at screening.
Exclusion criteria
✕. Normal-range serum parameters:
✕. Subjects with bone metabolic diseases besides osteoporosis:
✕. Other metabolic bone diseases, such as osteomalacia, osteogenesis imperfecta, Paget's disease；
✕. Cushing's syndrome;
✕. Hyperprolactinemia;
✕. Use of medications that affect bone metabolism before screening:
✕. History of malignancy within 5 years, or bone metastasis, except for tumors that are expected to be cured after treatment (such as completely resected in situ basal cell or squamous cell carcinoma of the skin, cervical cancer, or breast ductal carcinoma, etc.).