Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis

NCT06951776 | Not Yet Recruiting DMC

• 1 other identifier: M20250309
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Circadian Rhythm Disorders; Osteoporosis

Keywords

Teriparatide, osteoporosis, Chronotherapy

Outcome Measures

Primary Outcomes (3)

• Change of CTX from baseline after administration

  Compare the morning and evening dosing groups regarding the changes in serum CTX from baseline after 4 and 12 weeks of subcutaneous injection of teriparatide.

  Within 12 weeks

• Change of P1NP from baseline after administration

  Compare the morning and evening dosing groups regarding the changes in serum P1NP from baseline after 4 and 12 weeks of subcutaneous injection of teriparatide.

  Within 12 weeks

• Change of PTH from baseline after administration

  Compare the morning and evening dosing groups regarding the changes in serum PTH from baseline after 4 and 12 weeks of subcutaneous injection of teriparatide.

  Within 12 weeks

Secondary Outcomes (1)

• Safety Evaluation

  Within 12 weeks

Study Arms (2)

Morning (8:00) administration group of teriparatide

EXPERIMENTAL

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

Behavioral: Morning administration group of teriparatide

Evening (20:00) administration group of teriparatide

EXPERIMENTAL

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

Behavioral: Evening administration group of teriparatide

Interventions

Morning administration group of teriparatide 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).

Morning (8:00) administration group of teriparatide

Evening administration group of teriparatide 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

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Normal-range serum parameters:
• Intact PTH: 15-65 pg/mL Total calcium: 2.20-2.70 mmol/L.
• Subjects with bone metabolic diseases besides osteoporosis:
• Other metabolic bone diseases, such as osteomalacia, osteogenesis imperfecta, Paget's disease；
• Cushing's syndrome;
• Hyperprolactinemia;
• 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.
• 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.).
• Hypocalcemia and hypercalcemia.
• Elevated alkaline phosphatase of unknown cause.
• History of fractures.
• Uncontrolled comorbidities, including heart failure with New York Heart Association (NYHA) functional class III or above, glycated hemoglobin \>8.5%, and severe arrhythmias.
• Allergy to teriparatide.
• Currently participating in another drug clinical trial.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Related Publications (1)

• 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.

  PMID: 40676595 DERIVED

MeSH Terms

Conditions

Chronobiology Disorders; Osteoporosis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chunli Song, Dr

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Wang, Dr

CONTACT

13331151140; wanghuan1004@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: May 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share