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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)

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ClinicalTrials.gov Identifier: NCT00713258
Recruitment Status : Terminated (Slow enrolment)
First Posted : July 11, 2008
Results First Posted : October 7, 2011
Last Update Posted : May 8, 2012
Sponsor:
Information provided by (Responsible Party):
Nycomed

Brief Summary:

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 or disease Intervention/treatment Phase
Back Pain Drug: Parathyroid hormone (PTH) (1-84) Drug: Alendronate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale. [ Time Frame: Baseline and 24 weeks treatment ]
    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 :
  1. Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks treatment ]

    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.




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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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.

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 ClinicalTrials.gov identifier (NCT number): NCT00713258


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

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00713258     History of Changes
Other Study ID Numbers: FP-005-IM
First Posted: July 11, 2008    Key Record Dates
Results First Posted: October 7, 2011
Last Update Posted: May 8, 2012
Last Verified: May 2012

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
Metabolic Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Hormones
Alendronate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents