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:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT00781261
Eligibility Criteria:
Inclusion Criteria:
1. aged between 18-90 years,
2. symptoms of pain and disability in at least one hip joint, or
3. positive MRI findings stage I or II on the ARCO classification
Exclusion Criteria:
1. previous hip joint surgery on the affected hip
2. severe pain and disability at rest if treating clinician has recommended surgery
3. radiographic or MRI findings suggestive for stage III and IV on the ARCO classification
4. any iv bisphosphonate within the prior 2 years or any prior use of bisphosphonate preparations, except according to the washout schedule:
* 2 years (if use \> 48 weeks),
* 1 year (if used \> 8 weeks but \< 48 weeks)
* 6 months (if used \> 2 weeks but \< 8 weeks)
* 2 months (if used \< 2 weeks)
5. active primary hyperparathyroidism
6. hypothyroidism, not appropriately controlled with long-term thyroxine therapy
7. history of iritis or uveitis, except due to trauma, and resolved for \> 2 years prior to study
8. self-reported history of diabetic nephropathy or retinopathy (if diabetic, Hb A1c \> 10%)
9. urine dipstick greater than or equal to 2+ protein at screening
10. AST or ALT greater than twice the upper limit of normal and/or alkaline phosphatase greater than twice the upper limit of normal
11. serum calcium \> 2.75 mmol/L (11.0 mg/dL) or \< 2.00 mmol/L (8.0 mg/dL)
12. serum 25-hydroxyvitamin D concentrations \< 15 ng/L m) baseline renal insufficiency (calculated creatinine clearance less than 40 mL/min and serum creatinine greater than 175 mol/L) at V1
13. a history of invasive malignancy of any organ system, treated or untreated, in the past five years; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, ductal carcinoma in-situ (DCIS), and carcinoma in-situ (CIS) of the uterine cervix
14. any candidate patient with severe dental problems or current dental infections and/or any candidate patient with recent or impending dental surgery within three months of dosing
15. women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT00781261
Study Brief:
Protocol Section:
NCT00781261