OsteopeniaPhase 2NCT01292187
A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis
A Phase 2 study testing Oral calcitonin at dinnertime and Oral calcitonin at bedtime in people with Osteopenia, run by Tarsa Therapeutics, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Osteopenia
- What is being tested?
- Oral calcitonin at dinnertime and Oral calcitonin at bedtime
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2011to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Bethesda Health Research
Bethesda, Maryland, 20817
The Osteoporosis Center at St. Luke's Hospital
Chesterfield, Missouri, 63107
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Michigan Bone and Mineral Clinic
Detroit, Michigan, 48236
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705
University of Pittsburgh - Department of Neurology
Pittsburgh, Pennsylvania, 15213
Puget Sound Osteoporosis Center
Seattle, Washington, 98144
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating the Safety and Efficacy of Oral Recombinant Salmon Calcitonin (rsCT) in the Prevention of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture
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.
Read the detailed description
This was a randomized, double-blind, placebo-controlled Phase 2 study conducted entirely in the US. The subjects were all post-menopausal women whose 10-year risk of major osteoporotic fracture was assessed using the World Health Organization (WHO) Fracture Risk Assessment Tool (FRAX®) algorithm within the first 3 visits. Eligible, consenting subjects were then enrolled and began a 2- week single-blind placebo run-in phase to determine tolerability. After the run-in phase, continuing subjects were randomized in a 2:1 ratio to receive oral calcitonin or placebo. All subjects took 600 mg calcium citrate and 1000 IU vitamin D once daily with breakfast beginning with the run-in phase. The duration of treatment including the run-in phase was 54 weeks. Bone mineral density (BMD) and C-terminal telopeptide of type 1 collagen (CTx-1) were determined at Baseline and Weeks 28 and 54 after randomization. The % change from baseline in lumbar spine BMD was calculated and compared: active to placebo. The change from baseline in plasma CTx-1 was also calculated and compared likewise.
To confirm that there is no effect of meal timing on this product, subjects in both arms were further randomized to take the active or placebo on an empty stomach at bedtime or with the meal at dinnertime.
- Conditions
- Osteopenia
- Being tested
- Oral calcitonin at dinnertime, Oral placebo at dinnertime, Oral calcitonin at bedtime, Oral placebo at bedtime
- Keywords
- Osteoporosis, Osteopenia, Osteoporosis, Postmenopausal, Bone Diseases, Metabolic, Bone Diseases, Musculoskeletal Diseases, Salmon calcitonin, Calcitonin
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, Osteoporosis, Postmenopausal, Bone Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral calcitonin at dinnertimeDrug
Also called Oral rsCT
Oral calcitonin at dinnertime.
Oral placebo at dinnertimeDrug
Also called Placebo
Oral placebo at dinnertime.
Oral calcitonin at bedtimeDrug
Also called Oral rsCT
Oral calcitonin at bedtime
Oral placebo at bedtimeDrug
Also called Placebo
Oral placebo at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Oral calcitonin at dinner-or bedtime | Experimental | Intervention: Oral calcitonin at dinnertime or oral calcitonin at bedtime. Postmenopausal subjects with osteopenia were treated for one year (also with vitamin D and calcium supplements) to determine if oral calcitonin tablets would prevent the loss of bone mineral density compared with placebo. Randomization to active or placebo was done 2:1. After randomization, further randomization was done to divide each arm into two groups, one in which dosing was at dinnertime and the other in which dosing was at bedtime to determine if food affected efficacy or safety. Receives: Drug: Oral calcitonin at dinnertime; Drug: Oral calcitonin at bedtime |
| Oral placebo at dinner- or bedtime | Experimental | Intervention: oral placebo at dinnertime or oral placebo at bedtime Receives: Drug: Oral placebo at dinnertime; Drug: Oral placebo at bedtime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.
Measured: Baseline, Week 54
Secondary outcomes (1)
Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.
Measured: Baseline, Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsa Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David S. Krause, MD, Study director, Chief Medical Officer - Tarsa Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292187
- Sponsor's protocol ID
- TAR-01-201
- Status last verified
- Sep 2014
- First submitted
- 7 Feb 2011
- Last updated
- 12 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating the Safety and Efficacy of Oral Recombinant Salmon Calcitonin (rsCT) in the Prevention of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture
- ClinicalTrials.gov ID
- NCT01292187
- Acronym / sponsor ID
- TAR-01-201
- Conditions
- Osteopenia
- Keywords
- Osteoporosis, Osteopenia, Osteoporosis, Postmenopausal, Bone Diseases, Metabolic, Bone Diseases, Musculoskeletal Diseases, Salmon calcitonin, Calcitonin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Tarsa Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Posted 12 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a randomized, double-blind, placebo-controlled Phase 2 study conducted entirely in the US. The subjects were all post-menopausal women whose 10-year risk of major osteoporotic fracture was assessed using the World Health Organization (WHO) Fracture Risk Assessment Tool (FRAX®) algorithm within the first 3 visits. Eligible, consenting subjects were then enrolled and began a 2- week single-blind placebo run-in phase to determine tolerability. After the run-in phase, continuing subjects were randomized in a 2:1 ratio to receive oral calcitonin or placebo. All subjects took 600 mg calcium citrate and 1000 IU vitamin D once daily with breakfast beginning with the run-in phase. The duration of treatment including the run-in phase was 54 weeks. Bone mineral density (BMD) and C-terminal telopeptide of type 1 collagen (CTx-1) were determined at Baseline and Weeks 28 and 54 after randomization. The % change from baseline in lumbar spine BMD was calculated and compared: active to placebo. The change from baseline in plasma CTx-1 was also calculated and compared likewise.
To confirm that there is no effect of meal timing on this product, subjects in both arms were further randomized to take the active or placebo on an empty stomach at bedtime or with the meal at dinnertime.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral calcitonin at dinner-or bedtime | Experimental | Drug: Oral calcitonin at dinnertime, Drug: Oral calcitonin at bedtimeIntervention: Oral calcitonin at dinnertime or oral calcitonin at bedtime. Postmenopausal subjects with osteopenia were treated for one year (also with vitamin D and calcium supplements) to determine if oral calcitonin tablets would prevent the loss of bone mineral density compared with placebo. Randomization to active or placebo was done 2:1. After randomization, further randomization was done to divide each arm into two groups, one in which dosing was at dinnertime and the other in which dosing was at bedtime to determine if food affected efficacy or safety. |
| Oral placebo at dinner- or bedtime | Experimental | Drug: Oral placebo at dinnertime, Drug: Oral placebo at bedtimeIntervention: oral placebo at dinnertime or oral placebo at bedtime |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral calcitonin at dinnertimeAlso: Oral rsCTOral calcitonin at dinnertime. | Drug | Oral calcitonin at dinner-or bedtime |
| Oral placebo at dinnertimeAlso: PlaceboOral placebo at dinnertime. | Drug | Oral placebo at dinner- or bedtime |
| Oral calcitonin at bedtimeAlso: Oral rsCTOral calcitonin at bedtime | Drug | Oral calcitonin at dinner-or bedtime |
| Oral placebo at bedtimeAlso: PlaceboOral placebo at bedtime | Drug | Oral placebo at dinner- or bedtime |
Primary outcome
Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.
Time frame: Baseline, Week 54
1 secondary outcome
Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.
Time frame: Baseline, Week 54
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related Info.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S. Krause, MD study director
Chief Medical Officer - Tarsa Therapeutics, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral calcitonin at dinnertime and Oral calcitonin at bedtime in people with Osteopenia, run by Tarsa Therapeutics, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo. (time frame: Baseline, Week 54). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.