PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis

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