Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients

Phase 4

• Conditions: Osteoporosis
• Interventions: Drug: Denosumab treatment in osteoporotic patients; Drug: Teriparatide treatment in osteoporotic patients; Drug: Denosumab and teriparatide treatment in osteoporotic patients

• Registration Number: NCT02156960
• Lead Sponsor: Shinshu University

Brief Summary

It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-31
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Primary Completion: 2015-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Osteoporotic patients

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Denosumab and/or teriparatide treatment	Denosumab treatment in osteoporotic patients	Denosumab and/or teriparatide treatment in osteoporotic patients
Denosumab and/or teriparatide treatment	Teriparatide treatment in osteoporotic patients	Denosumab and/or teriparatide treatment in osteoporotic patients
Denosumab and/or teriparatide treatment	Denosumab and teriparatide treatment in osteoporotic patients	Denosumab and/or teriparatide treatment in osteoporotic patients

Primary Outcome Measures

Name	Time	Method
Changes of bone mineral density	every 4-6 months	Bone mineral density will be examined every 4-6 months to evaluate the suitability of the drug.

Secondary Outcome Measures

Name	Time	Method
Changes of bone turnover markers	every 3-6 months	Bone turnover markers will be examined every 3-6 months to evaluate the suitability of the drug.

Trial Locations

Locations (1)

Yukio Nakamura; 🇯🇵 Matsumoto, Nagano, Japan