PTH & Ibandronate Combination Study (PICS)

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The intension is to provide other options for treatment than the current standard 2 year course of drug therapy. These options may lead to treatment where the two years of therapy are spread over several years.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Diphosphonates; Ibandronic Acid; Parathyroid Hormone

Criteria

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 <= -1.5 either at the spine or the femoral neck or total hip OR have a T-score <= -1.0 with at least one of the following risk factors for fracture: 1)Age >= 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 <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