Conditions: Osteoporosis
Keywords: Lumbar Spine Bone Mineral Density (BMD)
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 407
Healthy volunteers: no

Brief summary:
The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Parathyroid Hormone (PTH) intervention 2: Risedronate
Intervention descriptions: intervention 1: Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen. intervention 2: Orally once weekly as one 35 mg tablet.

Protocol document: