The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)

This study has been terminated.
(Slow enrolment)
Sponsor:
Information provided by (Responsible Party):
Nycomed
ClinicalTrials.gov Identifier:
NCT00713258
First received: July 2, 2008
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

Secondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).


Condition Intervention Phase
Back Pain
Drug: Parathyroid hormone (PTH) (1-84)
Drug: Alendronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 24-week, International, Multi Centre, Randomised, Double-blind, Double-dummy, Parallel Group, Phase IV Clinical Trial Investigating Changes in Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) Treated With Either 100 µg PTH(1-84) Daily or 70 mg Alendronate Weekly

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale. [ Time Frame: Baseline and 24 weeks treatment ] [ Designated as safety issue: No ]
    The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = "no pain" and 10 = "unendurable pain").


Secondary Outcome Measures:
  • Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks treatment ] [ Designated as safety issue: No ]

    Three times during the trial the patients will be asked how their pain affects their ability to manage everyday life. This information will be collected by use of the Oswestry Disability Index (ODI) questionnaire. The questions relate to daily life activities and indicate to what extent a person's functional level is restricted by pain.

    ODI scores from 0 = "no disability" to 100 = "maximum disability".

    Patient reported outcomes will be assessed by using two questionnaires related to health status and quality of life status.



Enrollment: 75
Study Start Date: April 2008
Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PTH (1-84)
PTH (1-84) + placebo alendronate
Drug: Parathyroid hormone (PTH) (1-84)
100 µg PTH(1-84) daily
Active Comparator: Alendronate
PTH (1-84) placebo + alendronate
Drug: Alendronate
70 mg alendronate weekly

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women with a T-score ≤ -1.5 SD and at least one osteoporosis related vertebral fracture. Chronic back pain.

Exclusion Criteria:

  • Previous/current treatment and medical history.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713258

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00713258     History of Changes
Other Study ID Numbers: FP-005-IM
Study First Received: July 2, 2008
Results First Received: July 28, 2011
Last Updated: May 4, 2012
Health Authority: Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Nycomed:
Postmenopausal women
Back pain
Osteoporosis related fracture

Additional relevant MeSH terms:
Back Pain
Osteoporosis
Spinal Fractures
Fractures, Bone
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014