Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the timing of a medication called teriparatide affects bone health in women who are postmenopausal and have osteoporosis, a condition that weakens bones. The researchers want to find out if taking teriparatide in the morning or at night makes a difference in improving bone markers in the blood over a 12-week period. To participate, women must be between 60 and 70 years old, have been postmenopausal for at least five years, and have specific bone density measurements indicating osteoporosis.

Eligible participants will receive daily injections of teriparatide along with calcium and vitamin D supplements to support their bone health. The study aims to compare blood test results between those taking the medication in the morning versus those taking it at night, while also monitoring for any safety concerns throughout the trial. It’s important to note that certain health conditions or recent treatments might make someone ineligible to join. Overall, this study could help improve how osteoporosis is treated in postmenopausal women.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 60-70 years (inclusive).
• • 2. Naturally postmenopausal women with≥5 years since last menses.
• • 3. DXA-measured BMD T-score≤-3.0 at lumbar spine (L1-L4) and/or total hip at screening.
• • 4. 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.
• 5. Normal-range serum parameters:
• • Intact PTH: 15-65 pg/mL Total calcium: 2.20-2.70 mmol/L.
• Exclusion Criteria:
• 1. Subjects with bone metabolic diseases besides osteoporosis:
• • 1. Other metabolic bone diseases, such as osteomalacia, osteogenesis imperfecta, Paget's disease；
• • 2. Cushing's syndrome;
• • 3. Hyperprolactinemia;
• 2. 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.
• • 3. 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.).
• • 4. Hypocalcemia and hypercalcemia.
• • 5. Elevated alkaline phosphatase of unknown cause.
• • 6. History of fractures.
• • 7. Uncontrolled comorbidities, including heart failure with New York Heart Association (NYHA) functional class III or above, glycated hemoglobin \>8.5%, and severe arrhythmias.
• • 8. Allergy to teriparatide.
• • 9. Currently participating in another drug clinical trial.
• • 10. Subjects deemed unsuitable for enrollment in this study by the investigator.