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Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis

NCT02944799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2023-11-27

No results posted yet for this study

Summary

A randomized, double-blind, placebo-controlled trial including 160 consecutive patients who have been diagnosed with both rheumatoid arthritis (RA) and low bone mass and have been treated with alendronate (ALN) for five years or more. Patients will be randomized to discontinuation or continuation of alendronate. Outcomes are measured using dual energy absorptiometry (DXA), High Resolution peripheral Quantitative Computer Tomography (HR-pQCT) and biochemical markers of bone metabolism and inflammation after 6 months, 1 and 2 years.

Conditions

Interventions

DRUG

Placebo

Discontinuation of alendronate treatment

DRUG

Alendronate

DRUG

Calcium

Daily dietary supplement of 800mg calcium

DRUG

Vitamin D

Daily dietary supplement of 38 micrograms vitamin D

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Ellen Hauge, MD, PhD · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2021-12-20
Completion
2021-12-20

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02944799 on ClinicalTrials.gov