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

Osteoporosis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365456
• Other study ID #: FP-001-IM
• Secondary ID: 2005-000730-20U1
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2006
• Last updated: August 16, 2012
• Start date: July 2006
• Est. completion date: August 2011

Study information

• Verified date: August 2012
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesGreece: Ministry of Health and WelfareItaly: The Italian Medicines AgencySpain: Spanish Agency of MedicinesSweden: Medical Products AgencySwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: August 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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)?

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• Risedronate
Orally once weekly as one 35 mg tablet.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months	No