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)

Nycomed

Status and phase: Terminated; Phase 4

Conditions: Back Pain

Treatments: Drug: Parathyroid hormone (PTH) (1-84); Drug: Alendronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00713258

FP-005-IM

Details and patient eligibility

About

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).

Enrollment: 75 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

PTH (1-84)

Active Comparator group

Description:

PTH (1-84) + placebo alendronate

Treatment:

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

Alendronate

Active Comparator group

Description:

PTH (1-84) placebo + alendronate

Treatment:

Drug: Alendronate