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OpenTrials
Completed

NCT Number: NCT00365456

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Roskilde, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)?

Treatment and study plan

Parathyroid Hormone (PTH)

Drug

Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.

risedronate

Drug

Orally once weekly as one 35 mg tablet.

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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.

Acronym: PEAK

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Aug 17, 2006
Registry last updated
Aug 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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