Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT01770106
Eligibility Criteria:
Inclusion Criteria:
* with a diagnosis of RA according to the 2010 new 2010 American College of Rheumatology/ European League Against Rheumatism classification criteria
* at an age over 18 years old
* have a lumbar spine, or total hip or distal radius T-score lower than -1.5 by DXA
* without severe deformity in metacarpophalangeal (MCP) joints which would influence the longitudinal assessment of HR-pQCT
* consent to receive alendronate if randomized to standard treatment group.
Exclusion Criteria:
* they have previous use of denosumab, teriparatide, alendronate or other anti-resorptive agents;
* they have a history of recent major gastrointestinal (GI) tract disease (e.g. oesophagitis or GI ulceration) or have experienced any previous adverse reaction to bisphosphonate therapy;
* they are receiving other bone-active drugs, such as hormonal replacement therapy, thyroxine, thiazide and diuretics;
* they have conditions affecting bone metabolism; contraindications to alendronate and denosumab (uncorrected hypocalcemia);
* they have unexplained hypocalcemia;
* they have severe renal impairment or serum creatinine level of \>200umol/L;
* they are pregnant or breastfeeding;
* they do not understand Chinese or are incompetent in giving consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01770106
Study Brief:
Protocol Section:
NCT01770106