NCT06951776

Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis

Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis: A Randomized Controlled Exploratory Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 60 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, controlled, and exploratory study designed to evaluate the chronotherapeutic effects of teriparatide administration in postmenopausal osteoporosis. The trial protocol was approved by the Peking University Third Hospital Medical Science Research Ethics Committee. This trial intends to enroll postmenopausal osteoporosis patients admitted to the Department of Orthopedics of Peking University Third Hospital. Subjects who meet the inclusion and exclusion criteria can be enrolled in this trial after signing the informed consent form. Each trial group plans to enroll 14 subjects, with a total of 28 subjects. Eligible participants will be randomly assigned (1:1) to either subcutaneous injection of 20 μg teriparatide at 08:00 a.m in the morning (Group A) and subcutaneous injection of 20 μg teriparatide at 20:00 p.m in the evening(Group B). The specific time of drug administration for each patient every day needs to be recorded in the diary card. All subjects will be given calcium (1000-1500 mg/day) and vitamin D (800-1200 IU/day) simultaneously during the trial.

Conditions

• Circadian Rhythm Disorders
• Osteoporosis

Interventions

Type	Name	Description
BEHAVIORAL	Morning administration group of teriparatide	Eligible participants will be randomly assigned (1:1) to either subcutaneous injection of 20 μg teriparatide at 08:00 a.m. in the morning (Group A) and subcutaneous injection of 20 μg teriparatide at 20:00 p.m. in the evening (Group B).
BEHAVIORAL	Evening administration group of teriparatide	Eligible participants will be randomly assigned (1:1) to either subcutaneous injection of 20 μg teriparatide at 08:00 a.m. in the morning (Group A) and subcutaneous injection of 20 μg teriparatide at 20:00 p.m. in the evening (Group B).

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-04-30
• Last updated: 2025-04-30