Bone LossEarly Phase 1NCT02554695
Osteoclast Inhibition and Bone Formation
A Early Phase 1 study testing denosumab in people with Bone Loss and Aging, run by Mayo Clinic at 1 site in United States.
Trial summary
This protocol addresses: 1) How gene expression changes in bone cells are affected by aging? 2) Is aging associated with decreased signaling between bone cells? 3) How does treatment with the osteoporosis medication denosumab affect bone cell signaling? Read more about this study
- Who is it for?
- Ages 25 to 80 years, women onlyHealthy volunteers can take part
- What is being tested?
- denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2015to 25 Oct 2016
- Phase
- Early Phase 1
- 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 25 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal premenopausal women aged 25-40 years
- normal postmenopausal women aged 60-80 years
- at least 5 yrs since their last menses
- follicle stimulating hormone (FSH) > 20 IU/L
Who cannot join
- Abnormality in any of the screening laboratory studies
- Presence of significant liver or renal disease
- Malignancy (including myeloma)
- Malabsorption
- Diabetes
- Hypoparathyroidism
Show all 24Show fewer
- Hyperparathyroidism
- Acromegaly
- Cushing's syndrome
- Hypopituitarism
- Severe chronic obstructive pulmonary disease
- Undergoing treatment with any medications that affect bone turnover, including the following:
- adrenocorticosteroids (> 3 months at any time or > 10 days within the previous yr)
- anticonvulsant therapy (within the previous year)
- pharmacological doses of thyroid hormone (causing decline of thyroid stimulating hormone below normal)
- calcium supplementation of > 1200 mg/d (within the preceding 3 months)
- bisphosphonates (within the past 3 yrs)
- denosumab
- estrogen (E) therapy within the past year
- treatment with a selective E receptor modulator within the past year
- teriparatide within the past yr
- Clinical history of osteoporotic fracture (vertebral, hip, or distal forearm)
- Recent (within the past 6 months) fracture
- Serum 25-hydroxyvitamin D levels of < 20 ng/ml
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Effects of Age and Osteoclast Inhibition on Bone Formation
This protocol addresses: 1) How gene expression changes in bone cells are affected by aging? 2) Is aging associated with decreased signaling between bone cells? 3) How does treatment with the osteoporosis medication denosumab affect bone cell signaling?
Read the detailed description
This protocol collectively addresses the following goals: 1) What are the changes in gene expression in osteoblasts and osteocytes that lead to impaired bone formation with aging; 2) Since recent work from the investigators' group has demonstrated that osteoclasts produce a number of growth factors and cytokines (coupling factors) that enhance osteoblast proliferation and/or differentiation, is aging associated with reduced osteoclast coupling factor production; and 3) If osteoclasts are markedly reduced using the FDA-approved medication for osteoporosis, denosumab, how does that effect the quantity of coupling factors in the bone microenvironment and the target genes of these coupling factors in osteoblasts?
- Being tested
- placebo, denosumab
- Keywords
- adrenergic
- 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.
placeboDrug
Also called saline
subcutaneous saline injection
denosumabDrug
Also called Prolia
single subcutaneous injection of denosumab 60 mg
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | single subcutaneous injection of placebo (normal saline) Receives: Drug: placebo |
| Denosumab | Active comparator | single subcutaneous injection of denosumab 60 mg Receives: Drug: denosumab |
| young normal premenopausal women | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression changes in bone cells
Ratio of selected genes as expressed between each of the 3 arms (i.e. relative runx2 gene expression levels in each arm).
Measured: 3 months
Secondary outcomes (1)
Osteoclast-osteoblast coupling factor changes
Ratio of selected genes as expressed between each of the 3 arms (i.e. relative runx2 gene expression levels in each arm).
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 posted18 Sep 2015 (estimated)
- Study start20 Oct 2015
- Primary completion25 Oct 2016
- Study completion25 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sundeep Khosla, M.D., Mayo Clinic
- Investigators
- Sundeep Khosla, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554695
- Sponsor's protocol ID
- 15-002313
- Status last verified
- Jan 2018
- First submitted
- 17 Sep 2015
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Age and Osteoclast Inhibition on Bone Formation
- ClinicalTrials.gov ID
- NCT02554695
- Acronym / sponsor ID
- 15-002313
- Keywords
- adrenergic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 25 Oct 2016 (actual)
- First posted
- 18 Sep 2015 (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.
This protocol addresses: 1) How gene expression changes in bone cells are affected by aging? 2) Is aging associated with decreased signaling between bone cells? 3) How does treatment with the osteoporosis medication denosumab affect bone cell signaling?
Detailed description
This protocol collectively addresses the following goals: 1) What are the changes in gene expression in osteoblasts and osteocytes that lead to impaired bone formation with aging; 2) Since recent work from the investigators' group has demonstrated that osteoclasts produce a number of growth factors and cytokines (coupling factors) that enhance osteoblast proliferation and/or differentiation, is aging associated with reduced osteoclast coupling factor production; and 3) If osteoclasts are markedly reduced using the FDA-approved medication for osteoporosis, denosumab, how does that effect the quantity of coupling factors in the bone microenvironment and the target genes of these coupling factors in osteoblasts?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebosingle subcutaneous injection of placebo (normal saline) |
| Denosumab | Active comparator | Drug: denosumabsingle subcutaneous injection of denosumab 60 mg |
| young normal premenopausal women | No intervention | –no intervention |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (24 listed)
- adrenocorticosteroids (> 3 months at any time or > 10 days within the previous yr)
- anticonvulsant therapy (within the previous year)
- pharmacological doses of thyroid hormone (causing decline of thyroid stimulating hormone below normal)
- calcium supplementation of > 1200 mg/d (within the preceding 3 months)
- bisphosphonates (within the past 3 yrs)
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 |
|---|---|---|
| placeboAlso: salinesubcutaneous saline injection | Drug | placebo |
| denosumabAlso: Proliasingle subcutaneous injection of denosumab 60 mg | Drug | Denosumab |
Primary outcome
Gene expression changes in bone cells
Time frame: 3 months
Ratio of selected genes as expressed between each of the 3 arms (i.e. relative runx2 gene expression levels in each arm).
1 secondary outcome
Osteoclast-osteoblast coupling factor changes
Time frame: 3 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 5 Jan 2018.
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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.
Sundeep Khosla, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing denosumab in people with Bone Loss and Aging, run by Mayo Clinic 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 24 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 5 Jan 2018. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Gene expression changes in bone cells (time frame: 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 5 Jan 2018.