Examining how teriparatide administration affects bone health before denosumab therapy
Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
PHASE2 · Shinshu University · NCT03702140
This study is testing how different lengths of teriparatide treatment can affect bone health in people with osteoporosis before they start denosumab therapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 120 Years |
| Sex | All |
| Sponsor | Shinshu University (other) |
| Drugs / interventions | denosumab |
| Locations | 1 site (Matsumoto, Nagano) |
| Trial ID | NCT03702140 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of different administration periods of teriparatide on bone metabolism and mineral density in patients with osteoporosis before starting denosumab therapy. Participants will be divided into three groups based on the duration of teriparatide treatment: less than 6 months, 6 to 12 months, and more than 12 months, followed by 24 months of denosumab treatment. The study aims to assess both the efficacy and any adverse events associated with these treatment regimens.
Who should consider this trial
Good fit: Ideal candidates for this study are osteoporotic patients who are considering treatment with teriparatide and denosumab.
Not a fit: Patients who are allergic to teriparatide or denosumab, or those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing osteoporosis treatment regimens, potentially improving bone health outcomes for patients.
How similar studies have performed: While there is ongoing research in osteoporosis treatments, this specific approach of varying teriparatide administration periods before denosumab therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Osteoporotic patients who want to take teriparatide and denosumab Exclusion Criteria: * Patients who are allergic to teriparatide or denosumab Patients who are pregnant or breast-feedin
Where this trial is running
Matsumoto, Nagano
- Yukio Nakamura — Matsumoto, Nagano, Japan (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoporosis