Study to investigate changes in BMD of the lumbar spine (LS) one year after treatment discontinuation in denosumab-treated women and in denosumab-treated women who received a single infusion of zoledronic acid after treatment discontinuation.

Phase 1

• Conditions: Treatment of patients with with postmenopausal osteoporosis; MedDRA version: 18.1Level: LLTClassification code 10050213Term: Prophylaxis against postmenopausal osteoporosisSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-000852-91-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-30
• Study Completion: 2020-02-01
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

Postmenopausal women with osteoporosis (T-score <-2.5) who reached a T score of >-2.5 on the LS spine and/or Fn Neck while on treatment with denosumab attending the outpatient clinic and willing to participate.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
i) secondary osteoporosis; ii) diseases that could affect bone metabolism other then osteoporosis; iii) medications that could affect bone metabolism; iv) history of any antiosteoporotic treatment other than denosumab prior to randomization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified