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View Clinical Trial (Medical Research Study)
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A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women - NCT00959764-11501 (Clinical Trial 306000)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy306000.aspx
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| City: |
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Mineola |
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State:
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NY |
| Zip Code: |
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11501 |
| Conditions: |
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Osteoporosis, Postmenopausal |
| Purpose: |
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The purpose of this study is to compare the effectiveness and tolerability of two
medications, calcitonin nasal spray and a tablet containing calcitonin, in postmenopausal
women with osteoporosis. Osteoporosis is the term used to describe a large group of
diseases, which are characterized by loss of bone density, which makes the bones weaker.
Osteoporosis often occurs in postmenopausal women.
Calcitonin is a hormone found in the human body. Together with other substances, it
regulates the concentration of calcium in the blood and inhibits the natural resorption of
bone. Both medications in this study contain salmon calcitonin (sCT), because this form of
calcitonin is more active than human calcitonin when used as a medicine.
The calcitonin Nasal Spray used in this study is registered and available to doctors in
United States for the treatment of osteoporosis. The medication being tested in this study
is an oral tablet form of salmon calcitonin.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Female and age 45 or over.
- Must have undergone the onset of spontaneous or surgical menopause. Spontaneous
menopause is defined as 12 months of spontaneous amenorrhea or 6 months of
spontaneous amenorrhea with serum FSH levels >40 mIU/mL or 6 weeks postsurgical
bilateral oophorectomy with or without hysterectomy.
- Diagnosis of osteoporosis on the basis of an axial lumbar spine, femoral neck or
total hip BMD which is below the mean for premenopausal women by a magnitude of at
least 2.5 SD or 2.0 SD, if there is a documented history of a vertebral fragility
fracture.
- Must have at least three contiguous lumbar vertebrae (L1-L4) that are evaluable by
DXA for BMD that is, without fracture or significant degenerative disease, as
determined by Bio-Imaging Technologies, Inc.
- A body mass index (BMI) of not greater than 35 (BMI = weight [kg]/height[m]2).
- No clinically significant abnormal findings in the medical history, physical exam or
nasal exam.
- No clinically significant abnormal laboratory values at the screening assessment.
- Patients must give written informed consent after reading the Patient Information and
Consent Form and having had the opportunity to discuss the study with the
Investigator.
Exclusion Criteria:
- History of severe allergic disease.
- History of metabolic and other bone diseases, including osteogenesis imperfecta,
osteomalacia, and Paget's disease.
- Vitamin D insufficiency defined as a 25 hydroxyvitamin D level <20 ng/mL.
- Use of any intravenous bisphosphonate in the past 24 months, or >2 doses of
intravenous bisphosphonate ever.
- Use of oral bisphosphonate before randomization, including investigational
bisphosphonates, unless: 1) less than 6 months of treatment and off for 6 months, or
2) 6 to 12 months of treatment and off for 2 years, or 3) More than 12 months of
treatment and off for 5 years
- Use of denosumab, fluoride, or strontium, ever.
- Use of parathyroid hormone analogs or other bone metabolic agents within 1 year
preceding randomization.
- Any condition or disease that may interfere with the ability to have a DXA scan or to
evaluate a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion,
pedicle screws, history of vertebroplasty, or degenerative disease that results in
insufficient number of evaluable lumbar vertebrae, or more than 1 lumbar vertebral
fracture in L1 through L4. (More than 4 vertebral fractures in T4 through L4;
Bilateral hip replacements)
- Use of anabolic steroids or androgens within 6 months preceding randomization.
- Use of Vitamin D metabolites and analogs, (e.g., calcitriol) within 3 months
preceding randomization). Note: Vitamin D supplementation is not exclusionary.
- Use of estrogen or estrogen-related drugs, for example, tamoxifen, tibolone, or
raloxifene within 3 months preceding randomization.
- Use of coumadin within 4 weeks preceding randomization or heparin within 1 week
preceding randomization.
- Chronic systemic treatment with glucocorticoids, hormone replacement therapy,
calcitonin or any other medication within the previous three months which, in the
opinion of the Investigator, would interfere with the study.
- Clinically relevant abnormal history, physical findings or laboratory values at the
pre-study screening assessment that could interfere with the objectives of the study
or the safety of the patient.
- Presence of acute or chronic illness or history of chronic illness which, in the
judgment of the Investigator, makes participation in the study medically
inappropriate.
- Uncontrolled hypertension, significant gastrointestinal abnormalities, uncontrolled
diabetes mellitus, significant coronary heart disease, any psychotic mental illness,
chronic allergic rhinitis, asthma, uncorrected endocrine dysfunction, or
significantly impaired hepatic, respiratory or renal function.
- Participation in any other clinical study within the previous 1 month.
- History of drug or alcohol abuse, or intake of more than 30 units of alcohol weekly.
- Possibility that the patient will not cooperate with the requirements of the
protocol.
- Any nasal abnormality, such as nasal polyps, that, in the opinion of the
Investigator, could interfere with absorption of intranasally administered test drug.
- Known sensitivity to sCT or excipients. |
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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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February 2, 2010 |
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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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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