PTH & Ibandronate Combination Study (PICS)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): PTH(1-84); Ibandronate; Placebo injection; Placebo pills
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): 1.4 mg injected subcutaneously (in the abdomen) daily; 150mg by mouth once monthly; Daily injections as placebo for PTS 1-84; Monthly pills as placebo for oral ibandronate
Other intervention name(s): In Europe, PTH(1-84) is marketed as Preotact.; Boniva
Intervention MeSH terms: Ibandronic Acid; Parathyroid Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Combination of PTH and ibandronate; Bone marker formation; Postmenopausal; Trabecular spine BMD