Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
44 participants
INTERVENTIONAL
2008-05-31
2011-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
PTH(1-84)
1.4 mg injected subcutaneously (in the abdomen) daily
Ibandronate
150mg by mouth once monthly
Placebo injection
Daily injections as placebo for PTS 1-84
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.
PTH(1-84)
1.4 mg injected subcutaneously (in the abdomen) daily
Ibandronate
150mg by mouth once monthly
Placebo injection
Daily injections as placebo for PTS 1-84
Placebo pills
Monthly pills as placebo for oral ibandronate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PTH(1-84)
1.4 mg injected subcutaneously (in the abdomen) daily
Ibandronate
150mg by mouth once monthly
Placebo injection
Daily injections as placebo for PTS 1-84
Placebo pills
Monthly pills as placebo for oral ibandronate
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
55 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dennis M. Black, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Francisco
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Li X, Kuo D, Schafer AL, Porzig A, Link TM, Black D, Schwartz AV. Quantification of vertebral bone marrow fat content using 3 Tesla MR spectroscopy: reproducibility, vertebral variation, and applications in osteoporosis. J Magn Reson Imaging. 2011 Apr;33(4):974-9. doi: 10.1002/jmri.22489.
Schafer AL, Burghardt AJ, Sellmeyer DE, Palermo L, Shoback DM, Majumdar S, Black DM. Postmenopausal women treated with combination parathyroid hormone (1-84) and ibandronate demonstrate different microstructural changes at the radius vs. tibia: the PTH and Ibandronate Combination Study (PICS). Osteoporos Int. 2013 Oct;24(10):2591-601. doi: 10.1007/s00198-013-2349-y. Epub 2013 Apr 16.
Schafer AL, Sellmeyer DE, Palermo L, Hietpas J, Eastell R, Shoback DM, Black DM. Six months of parathyroid Hormone (1-84) administered concurrently versus sequentially with monthly ibandronate over two years: the PTH and ibandronate combination study (PICS) randomized trial. J Clin Endocrinol Metab. 2012 Oct;97(10):3522-9. doi: 10.1210/jc.2012-1844. Epub 2012 Jul 12.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PICS001
Identifier Type: -
Identifier Source: org_study_id