A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis
Condition: Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal
Intervention: Oral calcitonin at dinnertime; Oral placebo at dinnertime; Oral calcitonin at bedtime; Oral placebo at bedtime
Intervention description: Oral calcitonin at dinnertime.; Oral placebo at dinnertime.; Oral calcitonin at bedtime; Oral placebo at bedtime
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 129.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Osteoporosis; Osteopenia; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Salmon calcitonin; Calcitonin

Summary:

      The primary purpose of this study was to evaluate the efficacy of oral calcitonin
      (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral
      density at increased risk of fracture. The secondary purpose of this study was to determine
      if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets
      administered at dinner or at bedtime.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and at least 45 years of age.

          -  Must have undergone the onset of spontaneous or surgical menopause more than 5 years
             prior to entry. Spontaneous menopause is defined as 12 months of spontaneous
             amenorrhea. Surgical menopause is defined as ≥ 6 weeks postsurgical bilateral
             oophorectomy with or without hysterectomy.

          -  Serum follicle-stimulating hormone (FSH) levels must be ≥ 30 mIU/mL.

          -  A body mass index (BMI) of not greater than 35 (BMI

             =weight [kg]/height[m]2).

          -  Bone mineral density (BMD) T-score between -1.0 and - 2.5 at the total hip, femoral
             neck, trochanter, or lumbar spine.

          -  Additional risk factors such that the 10 year risk of a major osteoporotic fracture or
             hip fracture risk is at least as great as a 65-year-old woman of the same race and BMI
             of 25 kg/m2 as determined by the FRAX algorithm .

          -  No clinically significant abnormal findings in the medical history or physical exam
             that would preclude participation in the investigator's opinion.

          -  No clinically significant abnormal laboratory values at the screening assessment.

          -  Subjects must give written informed consent after reading the Subject Information and
             Consent Form and having had the opportunity to discuss the study with the
             investigator.

        Exclusion Criteria:

          -  History of an osteoporotic fracture, defined as a fracture at the wrist, hip, or
             humerus occurring from a fall at standing height or less.

          -  BMD T-Score at any site ≤ -2.5.

          -  Current treatment (or within 3 months prior to randomization) with hormone replacement
             therapy.

          -  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 (50 nmol/L).

          -  Prior use of calcitonin, ever.

          -  Prior use of any bisphosphonate, ever.

          -  Prior use of denosumab, fluoride, or strontium, ever.

          -  Prior use of parathyroid hormone analogs, ever.

          -  Any condition or disease that may interfere with the ability to have a dual energy
             x-ray absorptiometry (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, 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 (including selective estrogen receptor
             molecules), for example, tamoxifen, tibolone, or raloxifene within 3 months preceding
             randomization.

          -  Chronic systemic treatment with glucocorticoids.

          -  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 subject.

          -  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.

          -  Known acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
             seropositivity.

          -  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 month.

          -  History of drug or alcohol abuse, or intake of more than 30 units of alcohol weekly.

          -  Possibility that the subject will not cooperate with the requirements of the protocol.

          -  Known sensitivity to sCT.

          -  Shift workers-individuals who are at work during overnight hours.