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Pharmacogenetic study on the clinical efficacy of anti-osteoporosis drugs in the treatment of primary osteoporosis

Pharmacogenetic study on the clinical efficacy of anti-osteoporosis drugs in the treatment of primary osteoporosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093018
Enrollment
Unknown
Registered
2024-11-27
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Interventions

Osteoporosis with anti-osteoporosis treatment group:NA

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=45 years; 2.Meet the diagnostic criteria for osteoporosis as outlined in Guidelines for the diagnosis and treatment of primary osteoporosis(2022)from Chinese Society of Osteoporosis and Bone Mineral Research; 3.Patients have received regular anti-osteoporosis drug treatment for at least 1 year, which includes one of the following regimens: oral alendronate 70 mg once weekly for at least 12 months, or intravenous infusion of zoledronic acid 5 mg (once per year) at least once, or subcutaneous injection of denosumab 60 mg (once every six months) at least twice, or subcutaneous injection of bone formation-promoting drug teriparatide 20 µg daily for at least 12 months; 4.The patient's medical history, bone density, and laboratory data are relatively complete upon review by the researcher; 5.Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with unstable secondary osteoporosis during treatment, such as those receiving stable doses of corticosteroids or patients with stable breast cancer undergoing endocrine therapy; 2.Patients with psychiatric disorders or those with cognitive dysfunction; 3.Poor medication adherence, with alendronate and teriparatide adherence =60 days in receiving two doses of denosumab treatment; 4.Patients with a history of allergies to or contraindications for the drugs used in the study; 5.Patients with significant liver or kidney dysfunction, defined as AST or ALT >= 2.5 times the upper limit of normal, or eGFR <= 60 ml/min*1.73m²; 6.Patients with a current history of cancer, or severe organ diseases such as heart, brain, or kidney conditions, except for those with stable differentiated thyroid cancer or early-stage breast cancer after surgery; 7.Patients whom the researcher deems unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Bone mineral density;Key regulatory genes of anti-osteoporosis drug metabolism;

Secondary

MeasureTime frame
Bone metabolism markers TRACP and P1NP;

Countries

China

Contacts

Public ContactMa Xiao

China-Japan Friendship Hospital

redapple3155@qq.com+86 10 8420 6792

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026