Bone turnover markers as predictors of treatment break outcome

Phase 1

• Conditions: Osteoporosis; MedDRA version: 19.0 Level: LLT Classification code 10031289 Term: Osteoporosis, unspecified System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-003110-27-DK
• Lead Sponsor: Bente Lomholt Langdahl, Dept. of Endocrinology and Internal Medicine, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-22
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

• Postmenopausal women (postmenopausal for at least two years)
• Men above 50 years
• Treatment for at least five years with alendronat
• BMD T-score total hip > -2.5
• BMD T-score lumbar spine (L1-L4) > -4
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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

• Any low-energy fracture within the previous 5 years during
alendronat treatment (not including fingers, toes, or skull)
• Low-energy vertebral fracture at any time
• Low-energy hip fracture at any time
• Ongoing treatment with glucocorticoids
• Metabolic bone disease
• Hormone replacement therapy
• Cancer
• Other conditions affecting bone metabolism

Study & Design

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