Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM) (PEAK)
This study has been completed.
Sponsor:
Nycomed: A Takeda Company
Information provided by (Responsible Party):
Takeda ( Nycomed: A Takeda Company )
ClinicalTrials.gov Identifier:
NCT00365456
First received: August 9, 2006
Last updated: August 16, 2012
Last verified: August 2012
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Purpose
The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Drug: Parathyroid Hormone (PTH) Drug: Risedronate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, International, Multi Centre, Parallel Group, Phase III b, Randomised Trial, Investigating Lumbar Spine Bone Mineral Density (BMD) Changes in Postmenopausal Women With Primary Osteoporosis Initially Treated With 12 Months of Full Length Parathyroid Hormone (PTH 1-84) Followed by 12 Months of Treatment With Risedronate Followed by Either 12 Months Treatment With PTH (1-84) or Risedronate. |
Resource links provided by NLM:
Further study details as provided by Takeda:
Primary Outcome Measures:
- Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III. [ Time Frame: 12 months ] [ Designated as safety issue: No ]BMD was measured by Dual X-ray Absorptiometry (DXA).
| Enrollment: | 407 |
| Study Start Date: | July 2006 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PTH (1-84) |
Drug: Parathyroid Hormone (PTH)
Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.
|
| Active Comparator: Risedronate |
Drug: Risedronate
Orally once weekly as one 35 mg tablet.
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Women above the age of 50 years with the diagnosis of postmenopausal primary osteoporosis may be enrolled in the trial if the following inclusion/exclusion criteria apply.
All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.
- Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
- Is the subject above 50 years old?
- Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator?
- Does the subject have primary osteoporosis with a lumbar spine T score < -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?
- Does the subject have a life expectancy of >3 years?
- Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?
Contacts and Locations More Information
No publications provided
| Responsible Party: | Takeda ( Nycomed: A Takeda Company ) |
| ClinicalTrials.gov Identifier: | NCT00365456 History of Changes |
| Other Study ID Numbers: | FP-001-IM, 2005-000730-20, U1111-1132-3246 |
| Study First Received: | August 9, 2006 |
| Results First Received: | May 4, 2012 |
| Last Updated: | August 16, 2012 |
| Health Authority: | France: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Greece: Ministry of Health and Welfare Italy: The Italian Medicines Agency Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Takeda:
|
Lumbar Spine Bone Mineral Density (BMD) |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Hormones Risedronic acid Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013