Roslindale, MANCT06389539Now EnrollingIRB Ready

Osteoporosis Clinical Trial in Roslindale, MA

Access cutting-edge osteoporosis treatment through this clinical trial at a research site in Roslindale. Study-provided care at no cost to qualified participants.

Sponsored by Hebrew SeniorLife

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Expert Care in Roslindale

Access osteoporosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related osteoporosis treatment provided free

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Check if you qualify for this osteoporosis clinical trial in Roslindale, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Roslindale

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Roslindale site if eligible
  4. 4Begin participation

About This Osteoporosis Study in Roslindale

This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women.

Sponsor: Hebrew SeniorLife

Who Can Participate

Inclusion Criteria

1\. Provided written informed consent.
2\. Stated availability throughout entire study period and willingness to fulfill all details of the protocol.
3\. Age 60 years and above.
4\. DXA-BMD of the hip and spine (T-score) \> -2.5. Women with a BMD T score ≤ -2.5 (i.e. women with low BMD indicating osteoporosis) will also be considered if they have decided not to accept the standard of care use of osteoporosis medications for the entire duration of their participation in the study.
5\. Women with a history of major low-trauma fragility fractures (hip, forearm, humerus, spine) since the age of 50 years will be considered if they are not currently using osteoporosis medications, or if they have decided not to accept the standard of care osteoporosis medications, even if diagnosed with osteoporosis during the screening procedure.
6\. Serum 25-hydroxyvitamin D ≥ 20 ng/mL.
7\. Normal renal function (eGFR \>50 ml/min).
8\. Have chosen to not accept the standard of care use of osteoporosis medications for the duration of the study.
9\. Willing to comply with protocol and report on compliance and side effects during the study period.

Exclusion Criteria

1\. BMI greater than 40 kg/m2.
2\. Participants consuming dietary supplements (fish oil, probiotics/prebiotics, and fiber) in the prior month, and unwilling to avoid these supplements for the duration of the study.
3\. Participants using osmotic laxatives \>1 per week and unwilling to avoid use for the duration of the study.
4\. Known or suspected allergies to probiotics, rice, edible fruit extract or berries.
5\. Antibiotic use in the past 3 months. Participants placed on an antibiotic after enrollment will be retained.
6\. History of drug and/or alcohol abuse at the time of enrolment.
7\. Presence of any of the following:
a. History of other bone disorders (e.g. Paget's disease).
b. History of moderate to severe scoliosis.
c. History of cancer other than skin cancer \<5 years in remission, autoimmune disease, immune problems such as AIDS, type 1 or 2 diabetes.
d. History of colon resection, any disease that could interfere with the intestinal barrier function such as ulcerative colitis, irritable bowel syndrome or Crohn's disease or any chronic bowel condition.
e. Women with untreated hyperparathyroidism.
f. History of chronic antibiotic use.
g. History of bariatric surgery.
h. History of partial colectomy.
i. History of pancreatic disease.
j. History of active hepatitis B, hepatitis C, cirrhosis, metabolic dysfunction-associated steatotitc liver disease (MASLD), fatty liver or chronic liver disease.
k. Current bone marrow disorders such as myelodysplastic syndrome or anemia requiring transfusions.
l. Abnormalities of the spine determined by the study physician to interfere with the assessment of bone mineral density.
m. Current smoking or use of nicotine products within the past 6 months.
n. Current use of marijuana and unwilling to abstain during the study period.
o. Major abdominal surgery within the last 3 months.
p. Colonoscopy within the last 1 month.
q. Colonoscopy planned in the next 18 months and unwilling to reschedule it.
r. Indwelling catheter, implanted hardware/prosthetic device or feeding tube.
s. Any medical condition that could interfere with the conduct of the study.
8\. Treatment with calcitonin, estrogens, selective estrogen receptor modulators, progestins, anabolic steroids, or glucocorticoids in the past 6 months.
9\. Treatment with bisphosphonates in the past 3 years.
10\. Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab or denosumab in the last year or current coumadin use.
11\. Current or previous treatment with glucagon-like peptide (GLP-1) receptor agonists in the last one year.
12\. Participation in other bone, diet, autoimmune, or GI related clinical trials in the last 6 months. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
13\. Participants who plan on changing diet and/or exercise regime during trial participation.
14\. Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN):
Serum 25-hydroxyvitamin D \<20 ng/mL
Renal dysfunction (eGFR ≤50 ml/min)
15\. Seated blood pressure greater than equal to 160 mm Hg or seated diastolic blood pressure greater than equal to 100mm Hg.
16\. Short Blessed Test score \>10 or judged by the research staff as unable to follow the study protocol.
17\. Any other condition that in the opinion of the investigator or study clinician would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Roslindale?

Yes, this clinical trial (NCT06389539) has an active research site in Roslindale, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Osteoporosis Treatment Options in Roslindale, MA

If you're searching for osteoporosis treatment options in Roslindale, MA, this clinical trial (NCT06389539) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Roslindale research site is actively enrolling participants for this clinical trial. You'll receive care from experienced osteoporosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all osteoporosis clinical trials near you to find additional studies recruiting in your area.

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