NCT06951776Not yet recruiting
Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis
Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis: A Randomized Controlled Exploratory Study
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 23 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Peking University Third Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT06951776
What you commit to
- Study type: Interventional
- Planned participants: 28
- From 1 May 2025 to the primary completion date, 30 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medications that affect bone metabolism before screening:
- Use of intravenous bisphosphonates, fluoride, or strontium within 2 years; Use of teriparatide or denosumab for osteoporosis within 6 months; Oral bisphosphonates for osteoporosis with the last dose within 1 year (if used within 1 year but with a cumulative use of ≤1 month, the subject is eligible); Continuous use of calcitonin for more than 3 months with the last dose within 1 year.
- Currently participating in another drug clinical trial.
Other illness
- Subjects with bone metabolic diseases besides osteoporosis:
- 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.).
- History of fractures.
- Allergy to teriparatide.
Lab values
- Elevated alkaline phosphatase of unknown cause.
- Uncontrolled comorbidities, including heart failure with New York Heart Association (NYHA) functional class III or above, glycated hemoglobin \>8.5%, and severe arrhythmias.
Other
- Hypocalcemia and hypercalcemia.
- Subjects deemed unsuitable for enrollment in this study by the investigator.
Who the study is looking for
- 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 exclusion criteria, it is allowed to retest the 25-OHD concentration after administering vitamin D to the subject.
- Normal-range serum parameters:
- Intact PTH: 15-65 pg/mL Total calcium: 2.20-2.70 mmol/L.
Age in the registry: 60 years to 70 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.