Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2016-003110-27-DK
EUCTR2016-003110-27-DK
Active, not recruiting
Phase 1

Bone turnover markers as predictors of treatment break outcome

Bente Lomholt Langdahl, Dept. of Endocrinology and Internal Medicine, Aarhus University Hospital0 sites140 target enrollmentJuly 22, 2016
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsOsteoporosisMedDRA version: 19.0 Level: LLT Classification code 10031289 Term: Osteoporosis, unspecified System Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsAlendronate

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
Bente Lomholt Langdahl, Dept. of Endocrinology and Internal Medicine, Aarhus University Hospital
Enrollment
140
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 22, 2016
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Bente Lomholt Langdahl, Dept. of Endocrinology and Internal Medicine, Aarhus University Hospital

Eligibility Criteria

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

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
  • •Other conditions affecting bone metabolism

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
A Study to investigate Bone turnover Markers in patients planned to receive tofacitinibRheumatoid arthritisMedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
EUCTR2018-003162-13-ITAZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA30
Recruiting
Not Applicable
Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint DiseaseOsteoporosisOsteoporosis, Steroid InducedInflammatory Rheumatism
NCT06395883Diakonhjemmet Hospital160
Recruiting
Not Applicable
effect of biochemical markers of bone turnover for treating and predicting fracture risk risk of metabolic bone diseaseosteoporosis
JPRN-UMIN000008979Osaka City University Graduate School of Medicine400
Recruiting
Not Applicable
effect of biochemical markers of bone turnover for predicting fracture risk and changes of the bone mineral density in a long-term cohort studyosteopenia
JPRN-UMIN000008977Osaka City University Graduate School of Medicine300
Completed
Not Applicable
Assessment of bone related bio-markers in patients with rheumatoid arthritis treated with Certolizumab pegolrheumatoid arthritis
JPRN-UMIN000029594Graduate School of Medicine, Osaka University Department of Respiratory Medicine and Clinical Immunology40