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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Parathyroid Hormone (PTH)
Risedronate
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Lumbar Spine Bone Mineral Density (BMD)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)?

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PTH (1-84)

Risedronate

Arm Description

Outcomes

Primary Outcome Measures

Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.
BMD was measured by Dual X-ray Absorptiometry (DXA).

Secondary Outcome Measures

Full Information

First Posted
August 9, 2006
Last Updated
August 16, 2012
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00365456
Brief Title
Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
Acronym
PEAK
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Lumbar Spine Bone Mineral Density (BMD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PTH (1-84)
Arm Type
Experimental
Arm Title
Risedronate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Parathyroid Hormone (PTH)
Intervention Description
Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.
Intervention Type
Drug
Intervention Name(s)
Risedronate
Intervention Description
Orally once weekly as one 35 mg tablet.
Primary Outcome Measure Information:
Title
Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.
Description
BMD was measured by Dual X-ray Absorptiometry (DXA).
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nycomed Clinical Trial Operations
Organizational Affiliation
Headquaters
Official's Role
Study Chair
Facility Information:
City
Roskilde
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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