Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-70
SponsorPeking University Third Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
The concentration of 25-hydroxyvitamin D (25-OH)D is ≥20 ng/ml. If the subject meets all other inclusion and
Disqualifiers
Other metabolic bone diseases, such as osteomalacia, osteogenesis imperfecta, Paget's disease；
Cushing's syndrome;
Hyperprolactinemia;
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.).
Trial design
Treatments tested in this trial
- Morning administration group of teriparatide
- Evening administration group of teriparatide
Treatment groups
28 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov