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:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00005005
Eligibility Criteria:
Inclusion Criteria:
* Aged between 55 and 85 years
* Postmenopausal (have not had any menses in the last 5 years)
* Have a bone mineral density scan (DXA) that can be evaluated at the spine AND at the hip with a T-score equal to or below -2.5 at the spine or the femoral neck or total hip OR T-score equal to or below -2.0 at the spine or the femoral neck or total hip and have at least one of the following risk factors for fracture: (a) age \> 65 years; (b) history of postmenopausal fracture (nonvertebral or vertebral); or (c) maternal history of hip fracture
* Willing and able to self-administer daily injections
Exclusion Criteria:
* Have used estrogen (oral or patch) for more than 1 month in the last 6 months or more than 12 months in the last 2 years
* History of more than 12 months of bisphosphonate use ever, or any use (\> 4 weeks) within the past 12 months
* History of rhPTH (recombinant human PTH) use
* Any major life-threatening illnesses
* Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C \> 10.0), or currently using insulin
* Vitamin D level \< 15 nanograms/ml
* History of kidney disease (creatinine \> 2.0 mg/dl)
* Renal insufficiency (creatinine clearance \< 40 mg/min)
* Any history of kidney stones
* Any history of hypercalciuria or currently have urine calcium/creatinine \>300 mg
* History of hypercalcemia, sarcoidosis, or hyperparathyroidism
* History of active or treated tuberculosis or other granulomatous disorders
* History of breast cancer, melanoma, or hematologic malignancy that has required treatment within the last 10 years
* History of bone cancer or any other metabolic bone disease that has required treatment within the last 10 years
* History of any other nonskin cancer that has required treatment within the last 10 years
* History of symptomatic esophageal reflux, achalasia or esophageal stricture
* Currently taking \> 7.5 mg systemic prednisone or equivalent per day
* Currently using \> two puffs, four times/day of inhaled steroids
* Currently taking anticoagulants or anticonvulsants
* Have used Calcitonin within the past 3 months
* Have used Raloxifene in the last 6 months or for more than 12 months in the last 2 years
* Have used Tamoxifen in the last 6 months or for more than 12 months in the last 2 years
* Have used fluoride for at least a month within the past 5 years
* Currently taking \> 1000 IU/day vitamin D or vitamin D analogues or metabolites
* Currently taking thyroid hormone replacement AND have a TSH \< 0.1mIU/L
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT00005005
Study Brief:
Protocol Section:
NCT00005005