PTH & Ibandronate Combination Study (PICS)

Exclusion Criteria

• •History of more than 12 months of oral bisphosphonate use ever, or any use (\>4 weeks) with the past 12 months. For those with 4 weeks to 12 months of previous use, a 24 month washout is required.
• •History of any IV bisphosphonate use.
• •History of more than 12 month of PTH use ever, or any use (\>4 weeks) with the past 12 months.
• •History of estrogen (oral or patch) more than one month in the last 6 months or for more than 12 months in the last 2 years.
• •Have type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C \> 10.0), or currently using insulin.
• •Have serum calcium \>10.2 mg/dl.
• •Have Vitamin D level \<15 nanograms/ml.
• •Have Stage III renal insufficiency where calculated creatinine clearance \< 40 ml/min by MDRD.
• •Have any history of kidney stones in the last 10 years.
• •Have any history of hypercalcuria or currently have urine calcium \>300 mg/24 hours.
• •Have any history of hypercalcemia.
• •Have any history of sarcoidosis.
• •Have any history of hyperparathyroidism.
• •Have any history of active or treated tuberculosis or other granulomatous disorders.
• •History of breast cancer, melanoma or hematologic malignancy which has required treatment within the last 10 years.
• •Any history of bone cancer or Paget's disease of bone
• •Any other metabolic bone disease which has required treatment within the last 10 years.
• •History of any other non-skin cancer which has required treatment within the last 10 years.
• •Have a documented history of symptomatic esophageal reflux, achalasia or esophageal stricture.
• •Be currently taking \> 7.5 mg systemic prednisone or equivalent per day or for more than 10 days in the last 3 months.
• •Be currently using \> 2 puffs, 4 times / day of inhaled steroids.
• •Be currently taking anticoagulants.
• •Be currently taking anticonvulsants that alter hepatic vitamin D clearance
• •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.
• •Be currently taking \> 1000 IU/day Vitamin D
• •Using Vitamin D analogues or metabolites.
• •Be currently taking thyroid hormone replacement AND have a TSH \< 0.1mIU/L.
• •Have any major life-threatening illness.
• •Concurrent enrollment in another double-blinded clinical treatment intervention study.
• •Life expectancy less than 3 years
• •Willing to discontinue all over the counter nutritional supplements