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

NCT00959764 | Completed Phase 3 Results DMC

• 2 other identifiers: UGL-OR08012008-003322-42
• Study Type: interventional
• Target: 565
• Locations: 6 countries
• Sites: 20

Brief 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.

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine

  Bone Mineral Density is measured by Dual-Energy X-ray Absorptiometry (DXA) body scans. Two scans were taken for each timepoint(baseline, week 24 and week 48) and the mean of the two values was entered. The primary outcome timepoint was 48 weeks, but if a patient did not complete the full study, then the 24 week BMD value was used as Last Observation Carried Forward. The percentage change from the baseline value, set as 0%, was recorded as the primary outcome measure.

  48 weeks

Secondary Outcomes (2)

• Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)

  24 weeks

• Change in Plasma CTx-1 From Baseline

  48 weeks

Study Arms (3)

Oral calcitonin and placebo nasal spray

EXPERIMENTAL

Intervention: Oral calcitonin tablet (along with placebo intranasal spray)

Drug: Oral Calcitonin Tablets

Intranasal calcitonin & oral placebo

ACTIVE COMPARATOR

Intervention: Commercially available, active comparator, intranasal calcitonin-salmon (plus matching oral placebo tablet).

Drug: Intranasal Calcitonin

Placebo: tablet & intranasal spray

PLACEBO COMPARATOR

Intervention: Both oral matching placebo tablets and matching intranasal placebo spray

Drug: Placebo tablets and placebo intranasal spray

Interventions

Oral Calcitonin Tablets DRUG

Oral Calcitonin tablets along with matching placebo intranasal spray

Also known as: rsCT tablets

Oral calcitonin and placebo nasal spray

Intranasal Calcitonin DRUG

Intranasal Calcitonin Spray

Also known as: Miacalcin and Miacalcic

Intranasal calcitonin & oral placebo

Placebo tablets and placebo intranasal spray DRUG

Oral Placebo Tablets/Intranasal placebo spray

Also known as: Matching placebos

Placebo: tablet & intranasal spray

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• Tarsa Therapeutics, Inc.: lead

Study Sites (20)

Rheumatology Associates of N. AL, P.C.

Huntsville, Alabama, 35801, United States

Location

Northern California Institute for Bone Health, Inc.

Oakland, California, 94609, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Bethesda Health Research Center/Bone Health Center of Bethesda

Bethesda, Maryland, 20817, United States

Location

801 N. 30th Street, Suite 6718

Omaha, Nebraska, 68131, United States

Location

New Mexico Clinical Research & Osteoporosis

Albuquerque, New Mexico, 87106, United States

Location

Bone Mineral Research Center

Mineola, New York, 11501, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

University of Wisconsin-Geriatrics & Endocrinology/Medical Sciences Center

Madison, Wisconsin, 53705, United States

Location

Diagnostic Consultative Centre, "Sveta Anna" EOOD Sofia (Rheumatology Outpatient Office)

Sofia, Sofia, 1784, Bulgaria

Location

Synexus Hungary Ltd

Budapest, 1036, Hungary

Location

Synexus SCM Sp zoo

Wroclaw, Wroclaw, 50-088, Poland

Location

Clinical Research Centres SA (Pty) Ltd

Gauteng, Pretoria, 0184, South Africa

Location

Synexus Thames Valley Clinical Research Centre

Reading, Berkshire, RG2 7AG, United Kingdom

Location

Synexus Midlands Clinical Research Centre

Edgbaston, Birmingham, B15 2SQ, United Kingdom

Location

Synexus Wales Clinical Research Centre

Llanishen, Cardiff, CF14 5GJ, United Kingdom

Location

Synexus Lancashire Clinical Research Centre

Chorley, Chorley, PR7 7NA, United Kingdom

Location

Synexus Scotland Clinical Research Centre

Clydebank, Glasgow, G81 2DR, United Kingdom

Location

Synexus Merseyside Clinical Research Centre

Waterloo, Liverpool, L22 0LG, United Kingdom

Location

Synexus Manchester Clinical Research Centre

Manchester, Manchester, M15 6SX, United Kingdom

Location

Related Publications (1)

• Binkley N, Bolognese M, Sidorowicz-Bialynicka A, Vally T, Trout R, Miller C, Buben CE, Gilligan JP, Krause DS; Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) Investigators. A phase 3 trial of the efficacy and safety of oral recombinant calcitonin: the Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) trial. J Bone Miner Res. 2012 Aug;27(8):1821-9. doi: 10.1002/jbmr.1602.

  PMID: 22437792 RESULT

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Calcitonin; salmon calcitonin

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroid Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. David Krause, Chief Medical Officer
• Organization: Tarsa Theapeutics, Inc.

dkrause@tarsatherapeutics.com

1-267-273-7940

Study Officials

• David Krause, M.D.

  Tarsa Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 19, 2013
• Results First Posted: November 19, 2013

Record last verified: 2013-09

Locations

ZA (1); US (9); HU (1); BU (1); GB (7); PL (1)