A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoporosis, Postmenopausal

In brief

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.

Key facts

Study ID

NCT00959764

Run by

Tarsa Therapeutics, Inc.

People needed

565

Starts

2009-06-01

Expected to finish

2011-02-01

Last updated by the study team

2013-11-19

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 Follicle Stimulating Hormone (FSH) levels >40 milli-international units (mIU)/milliliter (mL) or 6 weeks post-surgical 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.
• No clinically significant abnormal findings in the medical history, physical exam or nasal exam.
• No clinically significant abnormal laboratory values at the screening assessment.

You may not qualify if…

• 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.
• History of drug or alcohol abuse, or intake of more than 30 units of alcohol weekly.

Where it is running

• Rheumatology Associates of N. AL, P.C. — Huntsville, Alabama, United States
• Northern California Institute for Bone Health, Inc. — Oakland, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Bethesda Health Research Center/Bone Health Center of Bethesda — Bethesda, Maryland, United States
• 801 N. 30th Street, Suite 6718 — Omaha, Nebraska, United States
• New Mexico Clinical Research & Osteoporosis — Albuquerque, New Mexico, United States
• Bone Mineral Research Center — Mineola, New York, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• University of Wisconsin-Geriatrics & Endocrinology/Medical Sciences Center — Madison, Wisconsin, United States
• Diagnostic Consultative Centre, "Sveta Anna" EOOD Sofia (Rheumatology Outpatient Office) — Sofia, Sofia, Bulgaria
• Synexus Hungary Ltd — Budapest, Hungary
• Synexus SCM Sp zoo — Wroclaw, Wroclaw, Poland
• Clinical Research Centres SA (Pty) Ltd — Gauteng, Pretoria, South Africa
• Synexus Thames Valley Clinical Research Centre — Reading, Berkshire, United Kingdom
• Synexus Midlands Clinical Research Centre — Edgbaston, Birmingham, United Kingdom
• Synexus Wales Clinical Research Centre — Llanishen, Cardiff, United Kingdom
• Synexus Lancashire Clinical Research Centre — Chorley, Chorley, United Kingdom
• Synexus Scotland Clinical Research Centre — Clydebank, Glasgow, United Kingdom
• Synexus Merseyside Clinical Research Centre — Waterloo, Liverpool, United Kingdom
• Synexus Manchester Clinical Research Centre — Manchester, Manchester, United Kingdom

Full record on ClinicalTrials.gov

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