PTH & Ibandronate Combination Study (PICS) (PICS)

August 29, 2013 updated by: University of California, San Francisco

PTH & Ibandronate Combination Study (PICS): Optimizing the Use of PTH With Boniva (Pilot Randomized Controlled Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized double-blind clinical trial for the treatment of postmenopausal osteoporosis will be conducted and coordinated by study investigators who also participated in the investigator-initiated PaTH study. Final data analysis will compare the results from this trial with those from the PaTH study. In the PaTH study, 238 women between 55 and 85 years of age were randomized to receive either:

  1. PTH for 1 year followed by alendronate for 1 year
  2. PTH and alendronate for 1 year followed by alendronate for 1 year
  3. alendronate for 2 years
  4. PTH for 1 year followed by placebo for 1 year.

In the PICS 44 postmenopausal women between the ages of 55 to 75 years of age with osteoporosis who meet the inclusion/exclusion criteria,will be randomized to the following 2 treatment groups. Group A will received 6 months of monthly Ibandronate, plus daily PTH 1-84,100 μg; followed by 18 months of Ibandronate only. Group B will received 3 months of daily PTH 1-84,100 μg; followed by 9 months of monthly Ibandronate, over 2 years. Calcium (400-650 mg) and Vitamin D (400 IU) supplements will be provided to all participants.

The primary objective is to determine if, at 3 months, the women treated with the concurrent combination of PTH and ibandronate (Group A) show a significant increase in bone marker formation compared to baseline (unlike the combination PTH/alendronate-treated women in PaTH). This will be accessed by examining the change in the markers P1NP, BSAP and serum CTX.

As a secondary objective, we will compare the trabecular spine BMD measures of those treated with concurrent PTH/Ibandronate (Group A) to those who received 3 months of PTH followed by Ibandronate(Group B). Another secondary objective will be to compare changes between groups in trabecular bone and DXA spine BMD after 2 years of treatment.

Changes to the fat content of the vertebrae during a course of PTH therapy will be examined using MRI spinal spectroscopy. Crosstabulation of these changes against changes in trabecular BMD, should indicate an effect on measurements. As well, the effect of a second three-month course of PTH therapy in Group B is of major interest.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: 6 months both + 18 months oral only
Group A will receive 6 months of monthly oral ibandronate 150 mg, plus daily PTH 1-84, 1.4 mg; followed by 18 months of ibandronate only. Placebo injections will be given months 13-15. Calcium + Vitamin D supplements, plus multivitamins are provided.
Drug: PTH(1-84)
1.4 mg injected subcutaneously (in the abdomen) daily
Other Names:
  • In Europe, PTH(1-84) is marketed as Preotact.
Drug: Ibandronate
150mg by mouth once monthly
Other Names:
  • Boniva
Other: Placebo injection
Daily injections as placebo for PTS 1-84
Active Comparator: B: (3 months injection + 9 months oral) x 2 years
Group B will receive 3 months of daily PTH 1-84, 1.4 mg; followed by 9 months of monthly oral ibandronate, 150 mg in year 1. In year 2, the group will receive another 3 months of daily PTH 1-84; followed by 9 months of monthly ibandronate. Placebo monthly pills will be given months 1-3 and months 13-15, and placebo injections will be given months 4-6. Calcium + Vitamin D supplements, plus multivitamins are provided.
Drug: PTH(1-84)
1.4 mg injected subcutaneously (in the abdomen) daily
Other Names:
  • In Europe, PTH(1-84) is marketed as Preotact.
Drug: Ibandronate
150mg by mouth once monthly
Other Names:
  • Boniva
Other: Placebo injection
Daily injections as placebo for PTS 1-84
Other: Placebo pills
Monthly pills as placebo for oral ibandronate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P1NP (ng/ml) Change From Baseline.
Time Frame: Baseline, 3 months
After an overnight fast, serum was drawn at baseline and 1, 3, 6, 12, 15, 18 and 24 months. Samples were stored at -70C until batch assayed in a central laboratory. Serum N-propeptide of type I collagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) were measured by electrochemiluminescent immunoassay. Bone-specified alkaline phosphate (BAP) was measured by paramagnetic particle immunoassay. P1NP was the bone turnover marker upon which we based sample size calculations.
Baseline, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Trabecular Spine vBMD
Time Frame: Baseline, 24 months.
Areal bone mineral density (aBMD) at the lumbar spine, hip, and distal one-third radius was assessed by dual-energy X-ray absorption at baseline and 6, 12, 18, and 24 months. The precision for aBMD is 1.0%. Volumetric BMD and bone geometry in trabecular and cortical compartments were assessed by quantitative computed tomography (QCT) at the spine and hip. The left hip was used for analysis. The precision for trabecular spine vBMD measurement is 1.0%. Trabecular spine vBMD was our primary BMD outcome, thus the one presented here.
Baseline, 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Dennis M. Black, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 22, 2008

First Posted (Estimate)

May 23, 2008

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

August 29, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PICS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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