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Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis

ConditionsCircadian Rhythm DisordersOsteoporosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-70
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Morning (8:00) administration group of teriparatideExperimental treatment 1 intervention
Group B: Evening (20:00) administration group of teriparatideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 12 weeks
2

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.

Time frame
Within 12 weeks
3

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.

Time frame
Within 12 weeks

Secondary outcomes

1

Safety Evaluation

All adverse drug reactions that occurred during the trial.

Time frame
Within 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov

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