Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis

NCT02944799 | Completed Phase 2 DMC

• 1 other identifier: 2015-003638-28
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 6

Brief 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

Rheumatoid Arthritis; Osteoporosis

Outcome Measures

Primary Outcomes (3)

• Bone Mineral Density

  Change from baseline to 24 months

• C-terminal telopeptide crosslinks (CTX)

  serological marker of bone metabolism

  Change from baseline to 6 months

• Type 1 procollagen amino-terminal-propeptide (P1NP)

  serological marker of bone metabolism

  Change from baseline to 6 months

Study Arms (2)

Alendronate

ACTIVE COMPARATOR

Continues treatment with alendronate, 70mgs oral tablet once every week

Drug: Alendronate; Drug: Calcium; Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo tablets, one every week

Drug: Placebo; Drug: Calcium; Drug: Vitamin D

Interventions

Placebo DRUG

Discontinuation of alendronate treatment

Placebo

Alendronate DRUG

Alendronate

Calcium DRUG

Daily dietary supplement of 800mg calcium

Alendronate; Placebo

Vitamin D DRUG

Daily dietary supplement of 38 micrograms vitamin D

Alendronate; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (\> 18 years) with rheumatoid arthritis according to the ACR(1987 or 2010)/EULAR (2010) classification criteria (12)
• treated with alendronate for five years or more
• current T-score on DXA better than or equal to -2,5 (femoral) and -3,0 (vertebral)
• receiving treatment on an outpatient basis
• negative pregnancy test (serum HCG) prior to trial start and the use of contraception throughout the study period and for 1 month after conclusion of the study period for women of childbearing potential. Plasma T1/2 of ALN is less than 2 hours. The forms of contraception include: intrauterine device (IUD) and hormonal anticontraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy and bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrollment. Postmenopause will be confirmed by measurement of s-FSH prior to enrollment.
• ability and willingness to give written informed consent and to meet the requirements of the trial protocol.

You may not qualify if:

• history of hip fracture due to osteoporosis
• history of vertebral fracture of more than one vertebrae or other fragility fractures within the last three years (fingers and toes not included)
• osteonecrosis of the jaw.
• history of or ongoing systemic GC treatment within the last 6 months (intraarticular injections are approved)
• known allergy toward any components of the study medicine
• prior or ongoing treatment with other antiosteoporosis drugs such as hormone replacement therapy or teriparatide
• active malignant disease
• metabolic bone disease other than osteoporosis
• hypo- or hyperthyroidism
• hypocalcaemia
• impaired renal function (eGFR \<35ml/min)
• known disease of the esophagus that might impair the ability to swallow the tablets such as achalasia, dysphagia or strictures
• history of upper gastrointestinal disease within 1 year prior to enrollment such as peptic ulcer, upper GI bleeding, gastritis, duodenitis or surgical procedures to the upper GI-tract
• allergy towards any of the substances in the study medicine

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (6)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Hjørring Hospital

Hjørring, 9800, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoporosis

Interventions

Alendronate; Calcium; Vitamin D

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ellen Hauge, MD, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: October 26, 2016
• Study Start: December 1, 2015
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

DK (6)