Parathyroid Hormone (PTH) With Alendronate for Osteoporosis
Completed · Phase 2
Conditions studied: Osteoporosis
In brief
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.
Key facts
- Study ID
- NCT00005006
- Run by
- Helen Hayes Hospital
- People needed
- 140
- Starts
- 1987-09-01
- Expected to finish
- 2006-12-01
- Last updated by the study team
- 2015-08-19
Who can join
Age: 50 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Approximately 140 postmenopausal women, over 50, who have been on alendronate (at least 35 mg/week) for a period of at least 18 months.
- Lumbar spine or hip T-score at the time of recruitment must be equal to or below -2.5.
You may not qualify if…
- All subjects must have primary osteoporosis.
- Subjects cannot be on any other medications known to influence bone metabolism besides alendronate. Subjects can be on Synthroid if TSH is normal.
Where it is running
- Helen Hayes Hospital, Clinical Research Center — West Haverstraw, New York, United States
Full record on ClinicalTrials.gov
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