Back PainPhase 4NCT00713258

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)

A Phase 4 study testing Parathyroid hormone (PTH) (1-84) and Alendronate in people with Back Pain, run by Nycomed at 1 site in Denmark.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 50 years and older, women only
Conditions the study is for: Back Pain
What is being tested?: Parathyroid hormone (PTH) (1-84) and Alendronate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteDenmark
Study dates: Apr 2008to Sep 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Previous/current treatment and medical history.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Nycomed
Roskilde, 4000

Other trials in Denmark

About this study

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

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).

Conditions: Back Pain
Being tested: Parathyroid hormone (PTH) (1-84), Alendronate
Keywords: Postmenopausal women, Back pain, Osteoporosis related fracture
Medical subject headings: Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Parathyroid hormone (PTH) (1-84)Drug
100 µg PTH(1-84) daily
AlendronateDrug
70 mg alendronate weekly

Study groups in NCT00713258
Study group	Role	What they receive
PTH (1-84)	Active comparator	PTH (1-84) + placebo alendronate Receives: Drug: Parathyroid hormone (PTH) (1-84)
Alendronate	Active comparator	PTH (1-84) placebo + alendronate Receives: Drug: Alendronate

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.
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").
Measured: Baseline and 24 weeks treatment

Secondary outcomes (1)

Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of 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.
Measured: Baseline and 24 weeks treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Sep 2010

First posted11 Jul 2008 (estimated)
Study startApr 2008
Primary completionMay 2010
Study completionSep 2010

Why it stopped: Slow enrolment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00713258
Sponsor's protocol ID: FP-005-IM
Status last verified: May 2012
First submitted: 2 Jul 2008
Last updated: 8 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

All Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00713258
Acronym / sponsor ID: FP-005-IM
Conditions: Back Pain
Keywords: Postmenopausal women, Back pain, Osteoporosis related fracture
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow enrolment
Enrolment: 75 participants (actual)
Lead sponsor: NycomedIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: May 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 11 Jul 2008 (estimated)
Results: Posted 7 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
PTH (1-84)	Active comparator	Drug: Parathyroid hormone (PTH) (1-84)PTH (1-84) + placebo alendronate
Alendronate	Active comparator	Drug: AlendronatePTH (1-84) placebo + alendronate

Who may qualify

Ages: 50 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Previous/current treatment and medical history.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Parathyroid hormone (PTH) (1-84)100 µg PTH(1-84) daily	Drug	PTH (1-84)
Alendronate70 mg alendronate weekly	Drug	Alendronate

Primary outcome

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").

1 secondary outcome

Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment
Time frame: Baseline and 24 weeks treatment

Results and safety

Results posted to the registry on 7 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PTH (1-84)	41	36
Alendronate	34	28

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

Time frame: Baseline and 24 weeks treatment. Mean (Standard Deviation). Unit: points on a scale

Population analysed: The number of participants analyzed is "0", because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PTH (1-84)	1 of 41 (2.4%)	18 of 41 (43.9%)	Not reported
Alendronate	5 of 34 (14.7%)	13 of 34 (38.2%)	Not reported

Limitations and caveats (from the sponsor): Early termination leading to small number of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Back Pain

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Parathyroid hormone (PTH) (1-84) and Alendronate in people with Back Pain, run by Nycomed at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale. (time frame: Baseline and 24 weeks treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00713258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012.