Parathyroid Hormone (PTH) With Alendronate for Osteoporosis
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
This study investigates the effectiveness of parathyroid hormone (PTH) in combination with
alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are
using alendronate because it may help protect patients against any possible harmful effects
of PTH in cortical bone such as the long bones or hip. We are testing two different treatment
schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of
every 6 months in a cyclical fashion. The entire study is 21 months long; the active
treatment period is 18 months with a 6-month followup period.
The main effects we will look for in this study are changes in body chemicals that are signs
of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We
will randomly assign all study participants, who are women aged 50 and over, to either stay
on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for
3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily
alendronate.
Phase:
Phase 2
Details
Lead Sponsor:
Helen Hayes Hospital
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)