Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• Main ID: NCT02944799
• Date of registration: 27/06/2016
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis ALOSTRA
• Scientific 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
• Date of first enrolment: December 2015
• Target sample size: 69
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02944799
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Denmark

Contacts

• Name: Ellen Hauge, MD, PhD
• Affiliation: University of Aarhus

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Osteoporosis

Rheumatoid Arthritis

Intervention(s)

Drug: Alendronate

Drug: Placebo

Drug: Vitamin D

Drug: Calcium

Primary Outcome(s)

Bone Mineral Density [Time Frame: Change from baseline to 24 months]

Type 1 procollagen amino-terminal-propeptide (P1NP) [Time Frame: Change from baseline to 6 months]

C-terminal telopeptide crosslinks (CTX) [Time Frame: Change from baseline to 6 months]

Secondary ID(s)

2015-003638-28

Source(s) of Monetary Support

Please refer to primary and secondary sponsors