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A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women
This study is ongoing, but not recruiting participants.
First Received: August 14, 2009   Last Updated: February 4, 2010   History of Changes
Sponsor: Unigene Laboratories Inc.
Information provided by: Unigene Laboratories Inc.
ClinicalTrials.gov Identifier: NCT00959764
  Purpose

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.


Condition Intervention Phase
Osteoporosis, Postmenopausal
Drug: Oral Calcitonin
Drug: Nasal Calcitonin
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title: A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Parallel Group, 48-Week, Study of Oral Recombinant sCT Compared to Calcitonin Nasal Spray in Postmenopausal Osteoporotic Women

Resource links provided by NLM:


Further study details as provided by Unigene Laboratories Inc.:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone markers [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 520
Study Start Date: June 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Oral Calcitonin: Experimental Drug: Oral Calcitonin
Calcitonin tablets
Nasal Calcitonin: Active Comparator Drug: Nasal Calcitonin
Nasal Calcitonin Spray
Placebo: Placebo Comparator Drug: Placebo
Placebo Tablets/Nasal spray

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959764

  Show 20 Study Locations
Sponsors and Collaborators
Unigene Laboratories Inc.
Investigators
Study Director: Kristine A Erickson, Ph.D. Unigene Laboratories Inc.
  More Information

No publications provided

Responsible Party: Unigene Laboratories, Inc. ( Dr. Kristine A. Erickson, Senior Director of Clinical Affairs )
Study ID Numbers: UGL-OR0801, EudraCT No.: 2008-003322-42
Study First Received: August 14, 2009
Last Updated: February 4, 2010
ClinicalTrials.gov Identifier: NCT00959764     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Calcitonin
Vasodilator Agents
Physiological Effects of Drugs
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents
Cardiovascular Agents
Bone Diseases
Salmon calcitonin
Pharmacologic Actions
Calcitonin Gene-Related Peptide
Musculoskeletal Diseases
Therapeutic Uses
Osteoporosis, Postmenopausal

ClinicalTrials.gov processed this record on February 08, 2010