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Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis (ALOSTRA)

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ClinicalTrials.gov Identifier: NCT02944799
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Osteoporosis Drug: Placebo Drug: Alendronate Drug: Calcium Drug: Vitamin D Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis - Indication and Duration: A Randomized, Double-blind, Placebocontrolled Study to Evaluate the Effects of Discontinuation of Alendronate in Patients With Both Rheumatoid Arthritis and Low Bone Mass
Study Start Date : December 2015
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Alendronate
Continues treatment with alendronate, 70mgs oral tablet once every week
Drug: Alendronate
Drug: Calcium
Daily dietary supplement of 800mg calcium

Drug: Vitamin D
Daily dietary supplement of 38 micrograms vitamin D

Placebo Comparator: Placebo
Placebo tablets, one every week
Drug: Placebo
Discontinuation of alendronate treatment

Drug: Calcium
Daily dietary supplement of 800mg calcium

Drug: Vitamin D
Daily dietary supplement of 38 micrograms vitamin D




Primary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: Change from baseline to 24 months ]
  2. C-terminal telopeptide crosslinks (CTX) [ Time Frame: Change from baseline to 6 months ]
    serological marker of bone metabolism

  3. Type 1 procollagen amino-terminal-propeptide (P1NP) [ Time Frame: Change from baseline to 6 months ]
    serological marker of bone metabolism



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944799


Contacts
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Contact: Anne-Birgitte Blavnsfeldt, MD +4528442953 blavnsfeldt@clin.au.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Principal Investigator: Salome Kristensen, PhD         
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Sub-Investigator: Anne-Birgitte Blavnsfeldt, MD         
Hjørring Hospital Not yet recruiting
Hjørring, Denmark, 9800
Principal Investigator: Norah Thomsen, MD         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Principal Investigator: Hanne Lindegaard, PhD         
Silkeborg Regional Hospital Active, not recruiting
Silkeborg, Denmark, 8600
Vejle Hospital Active, not recruiting
Vejle, Denmark, 7100
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Ellen Hauge, MD, PhD University of Aarhus

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02944799     History of Changes
Other Study ID Numbers: 2015-003638-28
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Osteoporosis
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Metabolic Diseases
Vitamin D
Alendronate
Vitamins
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents