We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00365456
First Posted: August 17, 2006
Last Update Posted: August 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365456


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

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00365456     History of Changes
Other Study ID Numbers: FP-001-IM
2005-000730-20 ( EudraCT Number )
U1111-1132-3246 ( Registry Identifier: WHO )
First Submitted: August 9, 2006
First Posted: August 17, 2006
Results First Submitted: May 4, 2012
Results First Posted: July 20, 2012
Last Update Posted: August 20, 2012
Last Verified: August 2012

Keywords provided by Takeda:
Lumbar Spine Bone Mineral Density (BMD)

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Hormones
Risedronate Sodium
Etidronic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents