Conditions: Back Pain
Keywords: Postmenopausal women Back pain Osteoporosis related fracture
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 75
Healthy volunteers: no

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).

Detailed description:

Arms:
arm 1: PTH (1-84) + placebo alendronate arm 2: PTH (1-84) placebo + alendronate

Interventions: intervention 1: Parathyroid hormone (PTH) (1-84) intervention 2: Alendronate
Intervention descriptions: intervention 1: 100 µg PTH(1-84) daily intervention 2: 70 mg alendronate weekly

Protocol document: