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

NCT ID: NCT02156960

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2022-11-30

Brief Summary

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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

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Conditions

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Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Denosumab and/or teriparatide treatment

Denosumab and/or teriparatide treatment in osteoporotic patients

Group Type EXPERIMENTAL

Denosumab treatment in osteoporotic patients

Intervention Type DRUG

To examine the effectiveness of denosumab in osteoporotic patients

Teriparatide treatment in osteoporotic patients

Intervention Type DRUG

To examine the effectiveness of teriparatide in osteoporotic patients

Denosumab and teriparatide treatment in osteoporotic patients

Intervention Type DRUG

To examine the effectiveness of denosumab and teriparatide in osteoporotic patients

Interventions

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Denosumab treatment in osteoporotic patients

To examine the effectiveness of denosumab in osteoporotic patients

Intervention Type DRUG

Teriparatide treatment in osteoporotic patients

To examine the effectiveness of teriparatide in osteoporotic patients

Intervention Type DRUG

Denosumab and teriparatide treatment in osteoporotic patients

To examine the effectiveness of denosumab and teriparatide in osteoporotic patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Osteoporotic patients

Exclusion Criteria

* none
Minimum Eligible Age

1 Year

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shinshu University

OTHER

Sponsor Role lead

Responsible Party

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Yukio Nakamura

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yukio Nakamura

Matsumoto, Nagano, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Yukio Nakamura, MD, PhD

Role: CONTACT

+81-263-37-2659

Facility Contacts

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Yukio Nakamura, MD, PhD

Role: primary

+81-263-37-2659

References

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Nakamura Y, Kamimura M, Ikegami S, Mukaiyama K, Uchiyama S, Taguchi A, Kato H. Changes in serum vitamin D and PTH values using denosumab with or without bisphosphonate pre-treatment in osteoporotic patients: a short-term study. BMC Endocr Disord. 2015 Dec 15;15:81. doi: 10.1186/s12902-015-0077-3.

Reference Type DERIVED
PMID: 26666998 (View on PubMed)

Other Identifiers

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Deno-PTH2365

Identifier Type: -

Identifier Source: org_study_id

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