Postmenopausal OsteoporosisNCT00567606
Prevention of Osteoporosis in Breast Cancer Survivors
A study testing Strength/Weight Training & Drug/Supplement and Drug/Supplement only in people with Postmenopausal Osteoporosis, run by University of Nebraska at 4 sites in United States.
Trial summary
The purpose of this study is to test whether strength/weight training exercises enhance the effectiveness of calcium, vitamin D, and risedronate for the prevention and treatment of osteoporosis in postmenopausal breast cancer survivors. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Strength/Weight Training & Drug/Supplement and Drug/Supplement only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Apr 2002to 1 Dec 2007
- Phase
- Interventional
- 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 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- read, speak and understand English;
- be female;
- be between the ages of 35 and 75;
- have completed treatment (except tamoxifen) for stage 0, I or II breast cancer (i.e. surgery, chemotherapy, radiation) at least 6 months prior to admission to the study;
- be 1 year postmenopausal (12-months amenorrheic; subjects 55-years or younger with history of hysterectomy without oophorectomy must have it confirmed by two baseline measures of FSH >40 IU/ml);
- have a BMD T-score of -1.0 SD or lower at one or more sites (spine, hip or forearm); and
- have agreement of their primary care provider for participation in the study.
Who cannot join
- have a recurrence of their breast cancer;
- currently take hormone replacement therapy, bisphosphonates, calcitonin, raloxifene, calcitriol, or glucocorticosteroids.;
- currently do strength/weight training exercises or high impact exercises (such as running, jumping rope, high impact aerobic dance, martial arts, volleyball, or basketball) two to three times weekly;
- have a body mass index (BMI) equal to or greater than 35;
- have serum calcium, creatinine or TSH (if on thyroid therapy) outside the normal limits;
- have active gastrointestinal problems such as dysphagia, esophageal disease, gastritis, duodenitis, or ulcers;
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- have Paget=s disease;
- have renal disease (renal stones or serum creatinine levels greater than the upper normal limits);
- have a recent history of a spinal fracture (within the past 6 months);
- have features of an acute fracture on baseline spinal x-rays;
- have other concomitant conditions that prohibit strength/weight training exercises, calcium, or vitamin D intake.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Nebraska Medical Center, College of Nursing
Kearney, Nebraska, 68849-4510
University of Nebraska Medical Center, College of Nursing
Lincoln, Nebraska, 68588-0220
University of Nebraska Medical Center, College of Nursing
Omaha, Nebraska, 68198-5330
University of Nebraska Medical Center, College of Nursing
Scottsbluff, Nebraska, 69361-4939
About this study
The purpose of this study is to test whether strength/weight training exercises enhance the effectiveness of calcium, vitamin D, and risedronate for the prevention and treatment of osteoporosis in postmenopausal breast cancer survivors.
Read the detailed description
Each year, more than 192,200 women are diagnosed with breast cancer (Greenlee, Hill-Harmon, Murray, \& Thun, 2001). With an increase in early detection and improved therapies, more of these women have become survivors (Vassilopoulou-Sellin \& Theriault, 1994). However, many of these women are at increased risk for osteoporosis and the debilitating consequences. This increased risk occurs for two reasons. Over 50-70% of women under the age of 50 (premenopausal) who are treated with adjuvant chemotherapy experience ovarian failure and early menopause (Ali \& Twibel, 1994; Cobleigh et al., 1994; Samaan et al., 1978), resulting in a long postmenopausal period of estrogen deprivation. Breast cancer survivors also are at greater risk for osteoporosis because they usually are not candidates for hormone replacement therapy (HRT). Estrogen can influence the growth of cancer in women, especially those with estrogen receptor positive tumors (ER+), and at least 60% of women have ER+ breast cancer (DeVita, Hellman \& Rosenberg, 1997). While the use of HRT significantly reduces osteoporosis and the risk of forearm, vertebral, pelvic, and hip fractures in postmenopausal women (Cobleigh et al., 1994; Finkelstein, 1996), women with a history of breast cancer generally are not considered candidates for HRT. Without estrogen, women may lose up to 30% of their bone mass within the first 5-years postmenopause, with continued bone loss over time, but at a slower rate. Very little information has been reported on the incidence and treatment of osteoporosis in breast cancer survivors (Headley et al., 1998; Hosking et al., 1998).
Osteoporosis is a major risk factor for chronic disability and especially hip fractures. The majority of individuals with hip fractures never return to prefracture functional status and estimates of health care costs for individuals with osteoporosis exceed the costs for those with congestive heart failure or with asthma (U.S. Congress Office of Technology Assessment, 1994; Ray, Chan, Thamer \& Meltin, 1997). Prevention and treatment of osteoporosis, by increasing bone mineral density (BMD) and muscle strength, may decrease the chronic disabilities associated with osteoporosis and improve quality and quantity of life (Mahon, 1998). Research on effective alternatives to HRT for the prevention of osteoporosis in breast cancer survivors has been targeted as a priority area by the Office of Cancer Survivorship (Division of Cancer Control and Population Sciences) at the National Cancer Institute (Office of Cancer Survivorship, 1999). No reports were found in which the effectiveness of the combination of risedronate, calcium, and vitamin D (administered together and at the current recommended levels for postmenopausal women) was studied, nor has the effectiveness of the addition of long term progressive strength/weight training exercises been evaluated in this at risk population of breast cancer survivors.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Strength/Weight Training & Drug/Supplement, Drug/Supplement only
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength/Weight Training & Drug/SupplementOther
Also called Actonel
G1 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week and strength/weight training exercises for upper and lower extremities and the spine.
Drug/Supplement onlyCombination product
Also called Actonel
G2 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week, but do not participate in strength/weight training exercises.
| Study group | Role | What they receive |
|---|---|---|
| Strength/Weight Training | Experimental | Subjects in the G1 group receive drug/supplement combination and strength/weight training exercises for upper and lower extremities and the spine. Receives: Other: Strength/Weight Training & Drug/Supplement |
| Drug Supplement only | Experimental | Subjects in the G2 group receive drug/supplement combination, but do not participate in strength/weight training exercises. Receives: Combination Product: Drug/Supplement only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Bone Mineral Density (gm/cm2) will be measured by Dual-Energy X-ray Absorptiometry (DEXA) of the hip, spine and forearm
Measured: at 12, 24, and 36 months
Secondary outcomes (1)
Muscle Strength
Muscle Strength (peak torque/body weight at 60 degrees) will be assessed using BiodexTM Velocity Spectrum Evaluation (Medical Systems, Inc., 1993)
Measured: at baseline, 6, 12, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study start1 Apr 2002
- Primary completion1 Dec 2007
- Study completion1 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Nancy L Waltman, PhD, ARNP, Principal investigator, University of Nebraska Medical Center, College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567606
- Sponsor's protocol ID
- 0536-01-FB
- Other IDs
- 1R01NR007743-04
- Status last verified
- Nov 2023
- First submitted
- 3 Dec 2007
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Twiss JJ, Gross GJ, Waltman NL, Ott CD, Lindsey AM. Health behaviors in breast cancer survivors experiencing bone loss. J Am Acad Nurse Pract. 2006 Oct;18(10):471-81. doi: 10.1111/j.1745-7599.2006.00165.x.
PubMed 16999712Ott CD, Twiss JJ, Waltman NL, Gross GJ, Lindsey AM. Challenges of recruitment of breast cancer survivors to a randomized clinical trial for osteoporosis prevention. Cancer Nurs. 2006 Jan-Feb;29(1):21-31, quiz 32-3. doi: 10.1097/00002820-200601000-00004.
PubMed 16557117
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Osteoporosis in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00567606
- Acronym / sponsor ID
- 0536-01-FB
- Conditions
- Postmenopausal Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Apr 2002 (actual)
- Primary completion
- 1 Dec 2007 (actual)
- Study completion
- 1 Dec 2007 (actual)
- First posted
- 5 Dec 2007 (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 test whether strength/weight training exercises enhance the effectiveness of calcium, vitamin D, and risedronate for the prevention and treatment of osteoporosis in postmenopausal breast cancer survivors.
Detailed description
Each year, more than 192,200 women are diagnosed with breast cancer (Greenlee, Hill-Harmon, Murray, \& Thun, 2001). With an increase in early detection and improved therapies, more of these women have become survivors (Vassilopoulou-Sellin \& Theriault, 1994). However, many of these women are at increased risk for osteoporosis and the debilitating consequences. This increased risk occurs for two reasons. Over 50-70% of women under the age of 50 (premenopausal) who are treated with adjuvant chemotherapy experience ovarian failure and early menopause (Ali \& Twibel, 1994; Cobleigh et al., 1994; Samaan et al., 1978), resulting in a long postmenopausal period of estrogen deprivation. Breast cancer survivors also are at greater risk for osteoporosis because they usually are not candidates for hormone replacement therapy (HRT). Estrogen can influence the growth of cancer in women, especially those with estrogen receptor positive tumors (ER+), and at least 60% of women have ER+ breast cancer (DeVita, Hellman \& Rosenberg, 1997). While the use of HRT significantly reduces osteoporosis and the risk of forearm, vertebral, pelvic, and hip fractures in postmenopausal women (Cobleigh et al., 1994; Finkelstein, 1996), women with a history of breast cancer generally are not considered candidates for HRT. Without estrogen, women may lose up to 30% of their bone mass within the first 5-years postmenopause, with continued bone loss over time, but at a slower rate. Very little information has been reported on the incidence and treatment of osteoporosis in breast cancer survivors (Headley et al., 1998; Hosking et al., 1998).
Osteoporosis is a major risk factor for chronic disability and especially hip fractures. The majority of individuals with hip fractures never return to prefracture functional status and estimates of health care costs for individuals with osteoporosis exceed the costs for those with congestive heart failure or with asthma (U.S. Congress Office of Technology Assessment, 1994; Ray, Chan, Thamer \& Meltin, 1997). Prevention and treatment of osteoporosis, by increasing bone mineral density (BMD) and muscle strength, may decrease the chronic disabilities associated with osteoporosis and improve quality and quantity of life (Mahon, 1998). Research on effective alternatives to HRT for the prevention of osteoporosis in breast cancer survivors has been targeted as a priority area by the Office of Cancer Survivorship (Division of Cancer Control and Population Sciences) at the National Cancer Institute (Office of Cancer Survivorship, 1999). No reports were found in which the effectiveness of the combination of risedronate, calcium, and vitamin D (administered together and at the current recommended levels for postmenopausal women) was studied, nor has the effectiveness of the addition of long term progressive strength/weight training exercises been evaluated in this at risk population of breast cancer survivors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength/Weight Training | Experimental | Other: Strength/Weight Training & Drug/SupplementSubjects in the G1 group receive drug/supplement combination and strength/weight training exercises for upper and lower extremities and the spine. |
| Drug Supplement only | Experimental | Combination Product: Drug/Supplement onlySubjects in the G2 group receive drug/supplement combination, but do not participate in strength/weight training exercises. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- read, speak and understand English;
- be female;
- be between the ages of 35 and 75;
- have completed treatment (except tamoxifen) for stage 0, I or II breast cancer (i.e. surgery, chemotherapy, radiation) at least 6 months prior to admission to the study;
- be 1 year postmenopausal (12-months amenorrheic; subjects 55-years or younger with history of hysterectomy without oophorectomy must have it confirmed by two baseline measures of FSH >40 IU/ml);
Key exclusion criteria (11 listed)
- have a recurrence of their breast cancer;
- currently take hormone replacement therapy, bisphosphonates, calcitonin, raloxifene, calcitriol, or glucocorticosteroids.;
- currently do strength/weight training exercises or high impact exercises (such as running, jumping rope, high impact aerobic dance, martial arts, volleyball, or basketball) two to three times weekly;
- have a body mass index (BMI) equal to or greater than 35;
- have serum calcium, creatinine or TSH (if on thyroid therapy) outside the normal limits;
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 |
|---|---|---|
| Strength/Weight Training & Drug/SupplementAlso: ActonelG1 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week and strength/weight training exercises for upper and lower extremities and the spine. | Other | Strength/Weight Training |
| Drug/Supplement onlyAlso: ActonelG2 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week, but do not participate in strength/weight training exercises. | Combination product | Drug Supplement only |
Primary outcome
Bone Mineral Density
Time frame: at 12, 24, and 36 months
Bone Mineral Density (gm/cm2) will be measured by Dual-Energy X-ray Absorptiometry (DEXA) of the hip, spine and forearm
1 secondary outcome
Muscle Strength
Time frame: at baseline, 6, 12, 24, and 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Results publication: PubMed 16999712Twiss JJ, Gross GJ, Waltman NL, Ott CD, Lindsey AM. Health behaviors in breast cancer survivors experiencing bone loss. J Am Acad Nurse Pract. 2006 Oct;18(10):471-81. doi: 10.1111/j.1745-7599.2006.00165.x.
- Results publication: PubMed 16557117Ott CD, Twiss JJ, Waltman NL, Gross GJ, Lindsey AM. Challenges of recruitment of breast cancer survivors to a randomized clinical trial for osteoporosis prevention. Cancer Nurs. 2006 Jan-Feb;29(1):21-31, quiz 32-3. doi: 10.1097/00002820-200601000-00004.
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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.
Nancy L Waltman, PhD, ARNP principal investigator
University of Nebraska Medical Center, College of Nursing
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength/Weight Training & Drug/Supplement and Drug/Supplement only in people with Postmenopausal Osteoporosis, run by University of Nebraska at 4 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 7 inclusion and 11 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Mineral Density (time frame: at 12, 24, and 36 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 NCT00567606, which also lists 2 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 30 Nov 2023.