Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name ORACAL

NCTNCT00959764 (opens ClinicalTrials.gov in a new tab)Other idUGL-OR0801Other id2008-003322-42Other id2008

Overview

Status
Completed
Phase
Phase 3
Enrollment
565 participants (actual)
Sponsor
Tarsa Therapeutics, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
6 countries

United States, Bulgaria, Hungary, Poland, South Africa, United Kingdom

Start
Jun 2009
Primary completion
Feb 2011
Completion
Feb 2011
First posted
17 Aug 2009 (estimated)
Last update posted
19 Nov 2013 (estimated)
Conditions
Osteoporosis, Postmenopausal

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 3

    ORACAL

    NCT00959764

    Jun 2009 to Feb 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Oral Calcitonin TabletsDrug
  • Intranasal CalcitoninDrug
  • Placebo tablets and placebo intranasal sprayDrug

Arms3

  • Experimental

    Oral calcitonin and placebo nasal spray

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

  • Active comparator

    Intranasal calcitonin & oral placebo

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

  • Placebo comparator

    Placebo: tablet & intranasal spray

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 48 weeks

    Registry description

    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.

Secondary outcomes(2)
  1. Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)

    Time frame · 24 weeks

    Registry description

    Change from baseline in plasma CTx-1 at 24 and 48 weeks. CTx-1 is an accepted plasma biomarker as evidence of an effect on bone resorption and the effect of oral calcitonin was compared to that of intranasal calcitonin, both vs placebo.

  2. Change in Plasma CTx-1 From Baseline

    Time frame · 48 weeks

    Registry description

    Percent change from baseline of plasma CTx-1 at end of study=48 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 48 weeks

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

GroupValue (Percentage increase from baseline)Spread
Oral Calcitonin1.533.17
Nasal Calcitonin0.762.91
Placebo0.473.21
Secondary and other outcome results(2)
Secondary outcomeLeast squares mean· 24 weeks

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

GroupValue (percentage change from baseline)Spread
Oral Calcitonin-42.9341.99
Nasal Calcitonin-24.6441.61
Placebo-21.0962.46
Secondary outcomeLeast squares mean· 48 weeks

Change in Plasma CTx-1 From Baseline

GroupValue (Percentage change from baseline)Spread
Oral Calcitonin-29.9247.53
Nasal Calcitonin-11.4140.24
Placebo-11.8335.58

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oral CalcitoninPatients who only received oral calcitonin as an active treatment–20 / 26344 / 263
Nasal CalcitoninPatients who only received nasal calcitonin as active treatment–9 / 182146 / 182
PlaceboPatients who did not receive any active treatment–9 / 10483 / 104

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

11 results

A phase 3 trial of the efficacy and safety of oral recombinant calcitonin: the Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) trial.

Binkley et al. 2012Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 111

PMID 22437792DOI 10.1002/jbmr.1602PUB-22437792

Rights unknown11 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.