Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis

NCT ID: NCT06951776

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-12-30

Brief 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

Keywords

Teriparatide, osteoporosis, Chronotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Morning (8:00) administration group of teriparatide

A total of 14 subjects will be included. Teriparatide injection (20 µg, subcutaneous injection, once daily) will be administered in the morning (around 8:00 a.m.) every day for 12 weeks

Group Type: EXPERIMENTAL

Morning administration group of teriparatide

Intervention Type: BEHAVIORAL

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).

Evening (20:00) administration group of teriparatide

A total of 14 subjects will be included. Teriparatide injection (20 µg, subcutaneous injection, once daily) will be administered in the evening (around 20:00 p.m.) every day for 12 weeks

Group Type: EXPERIMENTAL

Evening administration group of teriparatide

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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.

Exclusion Criteria

5. Normal-range serum parameters:

Intact PTH: 15-65 pg/mL Total calcium: 2.20-2.70 mmol/L.

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunli Song, Dr

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Central Contacts

Huan Wang, Dr

Role: CONTACT

Phone: 13331151140

Email: wanghuan1004@bjmu.edu.cn

References

Wang H, Tao L, Liu D, Yan X, Li H, Song C. Timing optimization of teriparatide dosing for postmenopausal osteoporosis: a randomized controlled trial. J Orthop Surg Res. 2025 Jul 17;20(1):669. doi: 10.1186/s13018-025-06083-6.

Reference Type: DERIVED

PMID: 40676595 (View on PubMed)

Other Identifiers

M20250309

Identifier Type: -

Identifier Source: org_study_id