Conditions: Osteoporosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief summary:
The purpose of this trial is to assess the effects on serum calcium when teriparatide is used with active vitamin D in osteoporosis patients.

This study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment Period, and a 7-day Follow-up Period. Patients will take vitamin D and calcium supplementation from the Lead-in Period throughout the study. During the Treatment Period, daily administration of teriparatide will be added.

Detailed description:

Arms:
arm 1: Aspara-CA 600 milligrams (mg) and Alfarol 1.0 microgram (µg) administered orally once daily throughout the study. Teriparatide 20 µg administered subcutaneously once daily for 28 days during the Treatment Period.

Interventions: intervention 1: Teriparatide intervention 2: Aspara-CA 600 mg intervention 3: Alfarol 1.0 µg
Intervention descriptions: intervention 1: Administered subcutaneously during the Treatment Period intervention 2: Administered orally throughout the study intervention 3: Administered orally throughout the study

Protocol document: