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

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. Identifier: NCT00365456
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : July 20, 2012
Last Update Posted : August 20, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Parathyroid Hormone (PTH) Drug: Risedronate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
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.
Study Start Date : July 2006
Actual Primary Completion Date : January 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)?

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 identifier (NCT number): NCT00365456

Roskilde, Denmark
Sponsors and Collaborators
Study Chair: Nycomed Clinical Trial Operations Headquaters

Responsible Party: Takeda Identifier: NCT00365456     History of Changes
Other Study ID Numbers: FP-001-IM
2005-000730-20 ( EudraCT Number )
U1111-1132-3246 ( Registry Identifier: WHO )
First Posted: August 17, 2006    Key Record Dates
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:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
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