Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name PEAK

NCTNCT00365456 (opens ClinicalTrials.gov in a new tab)Other idFP-001-IMOther id2005-000730-20Other idU1111-1132-3246Other id2005
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
407 participants (actual)
Sponsor
Takeda · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Denmark

Start
Jul 2006
Primary completion
Jan 2011
Completion
Aug 2011
First posted
17 Aug 2006 (estimated)
Last update posted
20 Aug 2012 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009201020112012
  1. Ph 3

    PEAK

    NCT00365456

    Jul 2006 to Aug 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Parathyroid Hormone (PTH)Drug
  • RisedronateDrug

Arms2

  • Experimental

    PTH (1-84)

  • Active comparator

    Risedronate

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.

    Time frame · 12 months

    Registry description

    BMD was measured by Dual X-ray Absorptiometry (DXA).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 12 months

Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.

GroupValue (Percentage Change)Spread
PTH (1-84)1.0021.0037
Risedronate0.9901.0034

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PTH (1-84)Trial Period I SAEs and Trial Period III SAEs for subjects receiving PTH (1-84)–33 / 405365 / 405
RisedronateTrial Period II SAEs and Trial Period III SAEs for subjects receiving risedronate–32 / 28295 / 282

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)?

PepBank is a research reference. Talk to a doctor before you use any peptide.