A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Oral Calcitonin Tablets; Intranasal Calcitonin; Placebo tablets and placebo intranasal spray
Intervention description: Oral Calcitonin tablets along with matching placebo intranasal spray; Intranasal Calcitonin Spray; Oral Placebo Tablets/Intranasal placebo spray
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 565.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      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.
    

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