| City: |
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West Haverstraw |
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State:
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NY |
| Zip Code: |
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10993 |
| Conditions: |
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Osteoporosis |
| Purpose: |
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Osteoporosis is a disease that affects millions of individuals in the United States and
abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study
will compare continuous versus cyclic treatment with teriparatide combined with alendronate,
another drug for osteoporosis, or teriparatide alone in women with osteoporosis.
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| Study summary: |
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Osteoporosis is a serious bone disease that has become an important public health problem.
It causes significant loss of bone mass and increases the risk of both fracture and
architectural problems with the skeleton. Until recently, the treatments available for
osteoporosis primarily prevented further deterioration of bone by reducing the rate of
remodeling within the skeleton. This can reduce the risk of fracture by approximately 50%.
Teriparatide is a new type of drug for people with osteoporosis who are at high risk of
fracture. Teriparatide stimulates bone remodeling and can correct the underlying
architectural and bone mass abnormalities that are characteristic of osteoporosis. This
study will compare continuous versus cyclic treatment with teriparatide combined with
alendronate, another drug for osteoporosis, or teriparatide alone in women with
osteoporosis.
All participants in this 2-year study will first attend a screening visit that will include
a physical exam, blood draw, x-rays, EKG, and distribution of calcium and vitamin D
supplements. Participants will be separated into two groups according to the treatment they
have undergone over the year prior to study entry. Participants who have taken alendronate
for at least 1 year prior to study entry will be assigned to Protocol 1. Participants who
have not previously taken alendronate will be assigned to Protocol 2. Participants in both
protocols will be randomly assigned to one of the following three biopsy groups:
pre-treatment; early; or late. Participants in the pre-treatment biopsy group will have a
bone biopsy before treatment begins. Those participants in the early biopsy group will have
a biopsy at Week 7 of treatment, and those in the late group will have a biopsy at Month 7.5
of treatment.
Participants will also be randomly assigned to one of three treatment schedules.
Participants in Protocol 1 may be assigned to receive alendronate alone for 24 months;
teriparatide daily plus alendronate for 24 months; or teriparatide daily on and off for 3
months at a time plus alendronate for 24 months. Participants in Protocol 2 may be assigned
to receive only the supplements they were given during the screening visit; teriparatide
daily plus alendronate for 24 months; or teriparatide daily on and off for 3 months at a
time for 24 months. Participants will attend assessment visits at Weeks 4 and 7 and Months
3, 5, 6, 7.5, 9, 12, 15, 18, 21, and 24. Visits may include bone turnover measurements, bone
mass scans, walking tests, questionnaires, CT scans, and blood draws. |
| Criteria: |
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Inclusion Criteria:
- Diagnosis of osteoporosis or T score below -2 plus one or more osteoporosis related
fractures
- Two measurable vertebrae between L1 and L4
- Willing to undergo a single iliac crest biopsy after administration of 4 tetracycline
labels
Exclusion Criteria:
- Secondary causes of osteoporosis or presence of a skeletal disorder other than
osteoporosis
- Uses drugs likely to affect skeletal or calcium homeostasis
- Multiple vertebral fractures or severe degenerative changes with fewer than two
evaluable vertebrae
- Unwilling to undergo a single iliac crest biopsy
- History of allergy to tetracyclines, exposure to tetracyclines within the last year,
or any remote long term use of tetracyclines
- Current use of anti-resorptive medicines (other than alendronate for half the female
participants)
- Use of hormone therapy, estrogen therapy, raloxifene, or calcitonin within 6 months
before study entry
- Use of any bisphosphonate for more than 3 months within 2 years before study entry
(only applies to participants in Groups 4, 5, and 6)
- History of a kidney stone within 5 years before study entry or any history of
multiple kidney stones
- Hypercalcemia, hypercalciuria, or elevated parathyroid hormone (reduced
25-hydroxyvitamin D will be corrected prior to admission)
- Esophageal ulceration or stricture or known hypersensitivity to bisphosphonates
- History of external radiation therapy
- Unlikely or unable to complete the study, as determined by the investigators
- Illicit drug use or excessive alcohol consumption |
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| Study is available at: |
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Helen Hayes Hospital
West Haverstraw, NY 10993
United States
Primary Contact:
Nancy Barbuto
Email: barbuton@helenhayeshosp.org
Phone: 845-786-4804
Secondary Contact:
Nancy Barbuto, RN
Email: barbuton@helenhayeshosp.org
Phone: 845-786-4804 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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