Low Bone DensityNCT01656629
Stem Cell Recruitment in Osteoporosis Therapy
A study testing Teriparatide, Alendronate and calcium and vitamin D in people with Low Bone Density, run by Johns Hopkins University at 1 site in United States.
Trial summary
Osteoporosis is an important health problem in the rapidly-aging demographic. Fragility fractures are devastating consequences of osteoporosis. The most common treatment approach in osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN). Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Low Bone Density
- What is being tested?
- Teriparatide, Alendronate and calcium and vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 7 Aug 2020
- Phase
- Interventional
- 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 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women aged 50-80 years
- T score < -2.5 at lumbar spine, total hip or femoral neck on dual x-ray absorptiometry (DXA) OR T score < -1.5 with a personal or family history of fracture
Who cannot join
- Previous use of bisphosphonates or Teriparatide; current estrogen therapy; any other osteoporosis therapy in the past 6 months
- Metabolic bone disease other than osteoporosis
- Body mass index (BMI) < 18
- Weight > 325 lbs
- Current smoking or current alcohol use that exceeds 3 units of alcohol daily
- Use of medications known to affect bone metabolism
Show all 22Show fewer
- Renal disease, history of kidney stones or hypercalciuria
- Hypo- or hyperparathyroidism; hypo- or hypercalcemia
- Serum vitamin D level < 20 ng/dL
- Refusal to adjust their dietary calcium to <750mg (i.e. two servings per day of calcium rich food)
- History of bone marrow or organ transplant
- History of malignancy or radiation to the bone
- History of esophageal stricture, dysmotility or severe reflux disease
- Gastrointestinal malabsorption
- Use of digoxin
- Need for chronic anticoagulation therapy such as Coumadin, heparin or low molecular weight heparin or inability to discontinue anti-platelet medication
- Bleeding diathesis; hemoglobin ≤ 12.5 g/dL (American Red Cross cut-off to donate blood)
- International normalized ratio (INR) pro time > 1.1 or activated partial thromboplastin time (APT) T ratio > 1.2
- Platelets < 150K/cu mm
- Cellulitis at site of iliac crest
- History of allergy to medications used in bone biopsy (demeclocycline, lidocaine)
- Inability to understand and provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Osteoporosis is an important health problem in the rapidly-aging demographic. Fragility fractures are devastating consequences of osteoporosis. The most common treatment approach in osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN). Parathyroid hormone (PTH) stimulates bone formation and is the only anabolic drug available. Dual therapy with ALN and PTH is not as effective as single-drug therapy in preventing fracture. Bone progenitor cells (MSCs) are recruited to sites of bone remodeling when a growth factor called Transforming Growth Factor Beta (TGF-β1) is released from bone. Different osteoporosis medicines may have differing effects on this process. The effects of ALN versus PTH on bone progenitor recruitment in humans are unknown. This is a randomized, clinical trial of ALN, PTH, and calcium and vitamin D in post-menopausal women with low bone mass. Women will be treated for 3 months with ALN or PTH or calcium and vitamin D. Data collected will include bone biopsies for histomorphometry and micro computed tomography (µCT), bone marrow aspirates for molecular studies, peripheral blood to detect circulating bone progenitor cells and dual X-ray absorptiometry. The investigators hypothesize that in humans, PTH will 1) increase bone progenitor number, 2) enhance recruitment of bone progenitor cells to bone resorption sites, and 3) increase bone progenitor number in peripheral circulation. Furthermore, the investigators hypothesize that ALN treatment will have the opposite effect. Understanding the differences in bone progenitor cell activity and recruitment during osteoporosis therapy will provide a mechanistic rationale for effective use of PTH and anti-resorptive drugs in osteoporosis treatment.
- Conditions
- Low Bone Density
- Being tested
- Teriparatide, Alendronate, calcium and vitamin D
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
20 mcg subq daily for 3 months
AlendronateDrug
70 mg weekly for 3 months
calcium and vitamin DDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| teriparatide | Active comparator | teriparatide 20 mcg sq for 3 months Receives: Drug: Teriparatide |
| Alendronate | Active comparator | 70 mg po weekly for 3 months Receives: Drug: Alendronate |
| calcium and vitamin D | Active comparator | calcium 630 mg vitamin D 500 units daily for 3 months Receives: Dietary Supplement: calcium and vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN).
Measured: up to 3 months
Secondary outcomes (2)
Difference in Bone Formation as Assessed by Bone Histomorphometry on Bone Biopsy Between Treatment Groups
Measured: 3 months
Difference in Osteogenic Potential of Bone Marrow as Measure by Colony Forming Unit Osteoblast (CFU-Ob) Assays Between Treatment Groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completion7 Aug 2020
Why it stopped: Inability to analyze collected samples due to no funds.
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 Low Bone DensityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Jan De Beur, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656629
- Sponsor's protocol ID
- NA_00050448
- Status last verified
- Aug 2020
- First submitted
- 1 Aug 2012
- Last updated
- 21 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cell Recruitment in Osteoporosis Therapy
- ClinicalTrials.gov ID
- NCT01656629
- Acronym / sponsor ID
- NA_00050448
- Conditions
- Low Bone Density
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to analyze collected samples due to no funds.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Posted 8 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoporosis is an important health problem in the rapidly-aging demographic. Fragility fractures are devastating consequences of osteoporosis. The most common treatment approach in osteoporosis is inhibition of bone resorption with drugs like alendronate (ALN). Parathyroid hormone (PTH) stimulates bone formation and is the only anabolic drug available. Dual therapy with ALN and PTH is not as effective as single-drug therapy in preventing fracture. Bone progenitor cells (MSCs) are recruited to sites of bone remodeling when a growth factor called Transforming Growth Factor Beta (TGF-β1) is released from bone. Different osteoporosis medicines may have differing effects on this process. The effects of ALN versus PTH on bone progenitor recruitment in humans are unknown. This is a randomized, clinical trial of ALN, PTH, and calcium and vitamin D in post-menopausal women with low bone mass. Women will be treated for 3 months with ALN or PTH or calcium and vitamin D. Data collected will include bone biopsies for histomorphometry and micro computed tomography (µCT), bone marrow aspirates for molecular studies, peripheral blood to detect circulating bone progenitor cells and dual X-ray absorptiometry. The investigators hypothesize that in humans, PTH will 1) increase bone progenitor number, 2) enhance recruitment of bone progenitor cells to bone resorption sites, and 3) increase bone progenitor number in peripheral circulation. Furthermore, the investigators hypothesize that ALN treatment will have the opposite effect. Understanding the differences in bone progenitor cell activity and recruitment during osteoporosis therapy will provide a mechanistic rationale for effective use of PTH and anti-resorptive drugs in osteoporosis treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| teriparatide | Active comparator | Drug: Teriparatideteriparatide 20 mcg sq for 3 months |
| Alendronate | Active comparator | Drug: Alendronate70 mg po weekly for 3 months |
| calcium and vitamin D | Active comparator | Dietary Supplement: calcium and vitamin Dcalcium 630 mg vitamin D 500 units daily for 3 months |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-menopausal women aged 50-80 years
- T score < -2.5 at lumbar spine, total hip or femoral neck on dual x-ray absorptiometry (DXA) OR T score < -1.5 with a personal or family history of fracture
Key exclusion criteria (22 listed)
- Previous use of bisphosphonates or Teriparatide; current estrogen therapy; any other osteoporosis therapy in the past 6 months
- Metabolic bone disease other than osteoporosis
- Body mass index (BMI) < 18
- Weight > 325 lbs
- Current smoking or current alcohol use that exceeds 3 units of alcohol daily
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 |
|---|---|---|
| Teriparatide20 mcg subq daily for 3 months | Drug | teriparatide |
| Alendronate70 mg weekly for 3 months | Drug | Alendronate |
| calcium and vitamin D | Dietary supplement | calcium and vitamin D |
Primary outcome
The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN).
Time frame: up to 3 months
2 secondary outcomes
Difference in Bone Formation as Assessed by Bone Histomorphometry on Bone Biopsy Between Treatment Groups
Time frame: 3 months
Difference in Osteogenic Potential of Bone Marrow as Measure by Colony Forming Unit Osteoblast (CFU-Ob) Assays Between Treatment Groups
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Suzanne Jan De Beur, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teriparatide, Alendronate and calcium and vitamin D in people with Low Bone Density, run by Johns Hopkins University 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 2 inclusion and 22 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: stopped early, as of the sponsor's last update on 21 Aug 2020. 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. 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?
Yes. Results are posted in the registry (first posted 8 Aug 2019). 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?
The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN). (time frame: up to 3 months). 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 21 Aug 2020.