Trial · Interventional

TerminatedPhase 4Results postedRegistry data

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)

NCTNCT00713258Other idFP-005-IM

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Slow enrolment

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 75 participants (actual)
Sponsor: Nycomed · Industry
Design: Randomized · Double masking
Countries: 1 country
Denmark
Start: Apr 2008
Primary completion: May 2010
Completion: Sept 2010
First posted: 11 Jul 2008 (estimated)
Last update posted: 8 May 2012 (estimated)
Conditions: Back Pain

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2008200920102011

Ph 4
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)
NCT00713258
Apr 2008 to Sept 2010
Terminated
Terminated

Registry summary

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

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).

Interventions

Parathyroid hormone (PTH) (1-84)Drug
AlendronateDrug

Arms2

Active comparator
PTH (1-84)
PTH (1-84) + placebo alendronate
Active comparator
Alendronate
PTH (1-84) placebo + alendronate

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.
Time frame · Baseline and 24 weeks treatment
Registry description
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 outcomes(1)

Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment
Time frame · Baseline and 24 weeks treatment
Registry description
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.

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 outcomeMean· Baseline and 24 weeks treatment

Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.

Group	Value (points on a scale)
PTH (1-84)	not posted
Alendronate	not posted

Secondary and other outcome results(1)

Secondary outcomeMean· Baseline and 24 weeks treatment

Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment

Group	Value (scores on a scale)
PTH (1-84)	not posted
Alendronate	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PTH (1-84)PTH (1-84) + placebo alendronate * PTH (1-84): powder and solvent for solution for injection * placebo alendronate: capsule	–	1 / 41	18 / 41
AlendronatePTH (1-84) placebo + alendronate * PTH (1-84) placebo: powder and solvent for solution for injection * alendronate: capsule	–	5 / 34	13 / 34

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: * 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.

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