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)

NCT ID: NCT00713258

Last Updated: 2012-05-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PTH (1-84)

PTH (1-84) + placebo alendronate

Group Type ACTIVE_COMPARATOR

Parathyroid hormone (PTH) (1-84)

Intervention Type DRUG

100 µg PTH(1-84) daily

Alendronate

PTH (1-84) placebo + alendronate

Group Type ACTIVE_COMPARATOR

Alendronate

Intervention Type DRUG

70 mg alendronate weekly

Interventions

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Parathyroid hormone (PTH) (1-84)

100 µg PTH(1-84) daily

Intervention Type DRUG

Alendronate

70 mg alendronate weekly

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nycomed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nycomed

Roskilde, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FP-005-IM

Identifier Type: -

Identifier Source: org_study_id

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