Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM) (PEAK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00365456
First received: August 9, 2006
Last updated: August 16, 2012
Last verified: August 2012
  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.

  1. 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).
  2. Is the subject above 50 years old?
  3. Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator?
  4. 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)?
  5. Does the subject have a life expectancy of >3 years?
  6. Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365456

Locations
Denmark
Roskilde, Denmark
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquaters
  More Information

No publications provided

Responsible Party: Takeda
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
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014