OsteoporosisPhase 4NCT00634686
Effects of Omega-3 Fatty Acids on Bone and Frailty
A Phase 4 study testing DHA/EPA and Calcium with vitamin D in people with Osteoporosis and Frailty, run by Donaghue Medical Research Foundation at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of essential fatty acid (EFA) supplementation on bone metabolism and frailty in postmenopausal women. The overall hypothesis is that EFA supplementation, via its immunoregulatory and anti-inflammatory activity, will decrease bone turnover, decrease prostaglandins and… Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Frailty
- What is being tested?
- DHA/EPA and Calcium with vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Postmenopausal women over 65 years old
- Spine or hip bone density T score less than -1
- Hand grip strength 2 standard deviations below weight adjusted norms
- Able to travel to the clinical sites for follow-up visits
Who cannot join
- Any disease that may affect bone metabolism, (i.e Paget's disease, primary hyperparathyroidism)
- Cancer of any kind (except basal or squamous cell of skin) in past 5 years.
- Use of calcitonin, calcitriol, heparin, phenytoin, phenobarbital, and estrogen in the past 6 months
- Use of bisphosphonates, long-term corticosteroids (more than 6 months), methotrexate, or fluoride at any time
- Current use of any medication or herbs with anticoagulant or antiplatelet activity, tetracycline, and magnesium or zinc supplementation
- Estimated creatinine clearance less than 50 ml/min
Show all 10Show fewer
- History of chronic liver disease or evidence of liver disease on screening
- History of hip fracture or known vertebral fracture within the past year
- Untreated hypertension or a history of clotting disorders
- History of allergy to fish or fish oil
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
The purpose of this study is to examine the effects of essential fatty acid (EFA) supplementation on bone metabolism and frailty in postmenopausal women. The overall hypothesis is that EFA supplementation, via its immunoregulatory and anti-inflammatory activity, will decrease bone turnover, decrease prostaglandins and cytokines associated with bone metabolism and frailty, and change physical outcome measures associated with frailty in postmenopausal women with low bone mass and frailty.
Read the detailed description
Osteoporosis is a bone thinning disease that results in fractures that occur with minimal trauma. The direct health care costs related to osteoporosis are estimated to be $14 billion per year, comparable to costs in heart failure and asthma. Frailty, or poor physiologic reserve to deal with stressors, is estimated to be 7% in the general population over age 65. The frailty syndrome is characterized by sarcopenia or muscle loss, inflammation, low estrogen, growth hormone and testosterone levels, poor nutrition and disability, and is associated with an increased risk of falls and fracture. Omega-3 fatty acids found in fish oil (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) have been shown to decrease markers of inflammation (cytokines) and decrease death due to heart disease. A number of studies in animals suggest that fish oil (EPA and DHA) supplementation inhibits bone break down, increases calcium absorbed from the diet and enhances calcium in bone. Few studies have assessed the role of n-6 and n-3 fatty acids in the diet in bone disease in humans. As far as we know, no study has evaluated the role of n-3 fatty acids in the frailty syndrome.
- Conditions
- Osteoporosis, Frailty
- Being tested
- DHA/EPA, Placebo capsule, Calcium with vitamin D
- Keywords
- Omega-3 fatty acids, immune response
- Medical subject headings
- Osteoporosis, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA/EPADietary supplement
1.2 gram capsule daily for 6 months
Placebo capsuleDietary supplement
daily for 6 months
Calcium with vitamin DDietary supplement
1000 mg of calcium with 1000 IU vitamin D daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: DHA/EPA; Dietary Supplement: Calcium with vitamin D |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo capsule; Dietary Supplement: Calcium with vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone turnover markers
Measured: baseline, 3 and 6 months
Secondary outcomes (4)
Bone Mineral Density
Measured: baseline, 3 and 6 months
Physical performance measures
Measured: baseline, 3 and 6 months
Blood pressure and lab work, including lipids, cytokines, prostaglandins, lymphocyte characterization, and EPA/DHA in blood and plasma
Measured: baseline, 3 and 6 months
Cognitive status, mood and depression
Measured: baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startJan 2007
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donaghue Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut
- Investigators
- Anne Kenny, MD, Principal investigator, University of Connecticut Center on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634686
- Sponsor's protocol ID
- AG0096
- Status last verified
- Jan 2009
- First submitted
- 11 Mar 2008
- Last updated
- 2 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Arlt W, Callies F, van Vlijmen JC, Koehler I, Reincke M, Bidlingmaier M, Huebler D, Oettel M, Ernst M, Schulte HM, Allolio B. Dehydroepiandrosterone replacement in women with adrenal insufficiency. N Engl J Med. 1999 Sep 30;341(14):1013-20. doi: 10.1056/NEJM199909303411401.
PubMed 10502590Callies F, Fassnacht M, van Vlijmen JC, Koehler I, Huebler D, Seibel MJ, Arlt W, Allolio B. Dehydroepiandrosterone replacement in women with adrenal insufficiency: effects on body composition, serum leptin, bone turnover, and exercise capacity. J Clin Endocrinol Metab. 2001 May;86(5):1968-72. doi: 10.1210/jcem.86.5.7483.
PubMed 11344193Morales AJ, Haubrich RH, Hwang JY, Asakura H, Yen SS. The effect of six months treatment with a 100 mg daily dose of dehydroepiandrosterone (DHEA) on circulating sex steroids, body composition and muscle strength in age-advanced men and women. Clin Endocrinol (Oxf). 1998 Oct;49(4):421-32. doi: 10.1046/j.1365-2265.1998.00507.x.
PubMed 9876338
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 Fatty Acids on Bone and Frailty
- ClinicalTrials.gov ID
- NCT00634686
- Acronym / sponsor ID
- AG0096
- Conditions
- Osteoporosis, Frailty
- Keywords
- Omega-3 fatty acids, immune response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Donaghue Medical Research FoundationUniversity, hospital or other
- Collaborators
- University of Connecticut
- Study start
- Jan 2007
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of essential fatty acid (EFA) supplementation on bone metabolism and frailty in postmenopausal women. The overall hypothesis is that EFA supplementation, via its immunoregulatory and anti-inflammatory activity, will decrease bone turnover, decrease prostaglandins and cytokines associated with bone metabolism and frailty, and change physical outcome measures associated with frailty in postmenopausal women with low bone mass and frailty.
Detailed description
Osteoporosis is a bone thinning disease that results in fractures that occur with minimal trauma. The direct health care costs related to osteoporosis are estimated to be $14 billion per year, comparable to costs in heart failure and asthma. Frailty, or poor physiologic reserve to deal with stressors, is estimated to be 7% in the general population over age 65. The frailty syndrome is characterized by sarcopenia or muscle loss, inflammation, low estrogen, growth hormone and testosterone levels, poor nutrition and disability, and is associated with an increased risk of falls and fracture. Omega-3 fatty acids found in fish oil (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) have been shown to decrease markers of inflammation (cytokines) and decrease death due to heart disease. A number of studies in animals suggest that fish oil (EPA and DHA) supplementation inhibits bone break down, increases calcium absorbed from the diet and enhances calcium in bone. Few studies have assessed the role of n-6 and n-3 fatty acids in the diet in bone disease in humans. As far as we know, no study has evaluated the role of n-3 fatty acids in the frailty syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: DHA/EPA, Dietary Supplement: Calcium with vitamin D |
| 2 | Placebo comparator | Dietary Supplement: Placebo capsule, Dietary Supplement: Calcium with vitamin D |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women over 65 years old
- Spine or hip bone density T score less than -1
- Hand grip strength 2 standard deviations below weight adjusted norms
- Able to travel to the clinical sites for follow-up visits
Key exclusion criteria (10 listed)
- Any disease that may affect bone metabolism, (i.e Paget's disease, primary hyperparathyroidism)
- Cancer of any kind (except basal or squamous cell of skin) in past 5 years.
- Use of calcitonin, calcitriol, heparin, phenytoin, phenobarbital, and estrogen in the past 6 months
- Use of bisphosphonates, long-term corticosteroids (more than 6 months), methotrexate, or fluoride at any time
- Current use of any medication or herbs with anticoagulant or antiplatelet activity, tetracycline, and magnesium or zinc supplementation
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 |
|---|---|---|
| DHA/EPA1.2 gram capsule daily for 6 months | Dietary supplement | 1 |
| Placebo capsuledaily for 6 months | Dietary supplement | 2 |
| Calcium with vitamin D1000 mg of calcium with 1000 IU vitamin D daily for 6 months | Dietary supplement | 1, 2 |
Primary outcome
Bone turnover markers
Time frame: baseline, 3 and 6 months
4 secondary outcomes
Bone Mineral Density
Time frame: baseline, 3 and 6 months
Physical performance measures
Time frame: baseline, 3 and 6 months
Blood pressure and lab work, including lipids, cytokines, prostaglandins, lymphocyte characterization, and EPA/DHA in blood and plasma
Time frame: baseline, 3 and 6 months
Cognitive status, mood and depression
Time frame: baseline, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2009.
- Background: PubMed 10502590Arlt W, Callies F, van Vlijmen JC, Koehler I, Reincke M, Bidlingmaier M, Huebler D, Oettel M, Ernst M, Schulte HM, Allolio B. Dehydroepiandrosterone replacement in women with adrenal insufficiency. N Engl J Med. 1999 Sep 30;341(14):1013-20. doi: 10.1056/NEJM199909303411401.
- Background: PubMed 11344193Callies F, Fassnacht M, van Vlijmen JC, Koehler I, Huebler D, Seibel MJ, Arlt W, Allolio B. Dehydroepiandrosterone replacement in women with adrenal insufficiency: effects on body composition, serum leptin, bone turnover, and exercise capacity. J Clin Endocrinol Metab. 2001 May;86(5):1968-72. doi: 10.1210/jcem.86.5.7483.
- Background: PubMed 9876338Morales AJ, Haubrich RH, Hwang JY, Asakura H, Yen SS. The effect of six months treatment with a 100 mg daily dose of dehydroepiandrosterone (DHEA) on circulating sex steroids, body composition and muscle strength in age-advanced men and women. Clin Endocrinol (Oxf). 1998 Oct;49(4):421-32. doi: 10.1046/j.1365-2265.1998.00507.x.
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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.
Anne Kenny, MD principal investigator
University of Connecticut Center on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DHA/EPA and Calcium with vitamin D in people with Osteoporosis and Frailty, run by Donaghue Medical Research Foundation at 1 site 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Bone turnover markers (time frame: baseline, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00634686, which also lists 3 linked publications.
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 2 Feb 2009.