PTH & Ibandronate Combination Study (PICS)

Inclusion Criteria

• Female
• Aged 55-75 years, inclusive, at randomization
• Postmenopausal for >= 5 years (no menses for at least 5 years)
• Have an evaluable bone mineral density scan (DXA) at the spine AND at the hip with a T-score = 65 years; 2)History of post-menopausal fracture (non-vertebral or vertebral); 3)Maternal history of hip fracture.
• Be willing and able to self-administer daily injections
• Signed written consent form.

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 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