Renal Transplant OsteodystrophyPhase 1/2NCT00266708

Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.

A Phase 1/2 study testing Risedronate in people with Renal Transplant Osteodystrophy, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Patients with kidney failure have underlying bone disease at the time of transplant. Fractures of various bones can be as high as 22%. Medication required for the transplant plays a role in bone loss. Bisphosphonates are used in the general population to treat bone loss of osteoporosis and steroid-induced bone loss. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Transplant Osteodystrophy
What is being tested?: Risedronate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Oct 2002to Jul 2008
Phase: Phase 1/2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults with end stage renal disease who are undergoing living donor kidney transplantation

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant

Bisphosphonates are used in the general population to treat bone loss of osteoporosis and steroid-induced bone loss. While previous studies, using various bisphosphonates, have shown preservation of bone mineral density in renal transplant recipients, we have demonstrated that pamidronate, a second generation bisphosphonate, is associated with low bone turnover while still preserving bone mineral density. Improved bone mineral density is associated with decreased fracture risk in the general population, while low bone turnover may be associated with increased fracture in dialysis patients.

The purpose of this study is to determine whether risedronate, a third generation bisphosphonate, is effective in preserving bone density when given prophylactically following renal transplantation and whether it is associated with low bone turnover at one year following renal transplantation.

Read the detailed description

Participants who receive a living donor kidney transplant undergo a bone biopsy at the time of kidney transplant and after one year of protocol. Once adequate kidney function is established, both groups take by mouth a weekly capsule (the control group has a placebo; the treatment group has risedronate 35 mg). Both groups undergo baseline, 6 month and 12 month dual energy x-ray absorptiometry (DEXA) bone mineral density scans. Both groups undergo bone hormonal studies at regular intervals.

Conditions: Renal Transplant Osteodystrophy
Being tested: Risedronate, Placebo
Keywords: renal transplant, post-transplant osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RisedronateDrug
Also called bisphosphonate
risedronate 35 mg weekly
PlaceboDrug
Also called Risedronate placebo
Risedronate Placebo 35 mg weekly

Study groups in NCT00266708
Study group	Role	What they receive
Risedronate	Experimental	subjects received Risedronate for one year Receives: Drug: Risedronate
subjects received placebo	Placebo comparator	subjects received placebo for 1 year Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Bone Mineral Density of Spine at 6 Months
Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner.
Measured: month 6 of the treatment
Bone Mineral Density of Spine at 12 Months
Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using same Hologic 4500 QDC scanner.
Measured: month 12 of treatment
Bone Mineral Density of the Hip at 6 Months
Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
Measured: month 6 of the treatment
Bone Mineral Density of the Hip at 12 Months
Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
Measured: month 12 of the treatment
Bone Mineral Density of Forearm at 6 Months
Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
Measured: month 6 of the treatment
Bone Mineral Density of Forearm at 12 Months
Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
Measured: month 12 of the treatment

Secondary outcomes (12)

Bone Histomorphometry - Percent Bone Volume (BV/TV)
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Percent Bone Volume is the percentage of total volume occupied by calcified bone. Percent Bone volume is calculated as Bone Volume (BV) divided by Tissue Volume (TV), where TV is bone plus marrow.
Measured: Baseline and month 12 of the treatment
Bone Histomorphometry - Trabecular Thickness (TbTh)
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. The ends of certain bones, known as cancellous bones, are actually not solid but are full of holes that are connected to each other by thin rods and plates of bone tissue known as trabeculae. Trabeculae of bone provide structural support to the spongy bone found at the ends of long bones. Trabeculae Trabecular Thickness (TbTh), a structural parameter, is the distance across individual trabecula.
Measured: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Percent Mineralized Bone Volume is the percentage of Bone Volume consisting of mineralized bone. Percent Mineralized Bone Volume is calculated as Mineralized Bone Volume (MdV) divided by Bone Volume (BV).
Measured: Baseline and month 12 of the treatment
Bone Histomorphometry - Mineralized Bone Volume (MdV)
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Bone mineralization is the process of laying down minerals on the matrix of the bone, with calcium and phosphorus as the most abundant minerals. Mineralized Bone Volume (MdV) is the percentage of mineralized bone tissue.
Measured: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of a given volume of bone that consists of unmineralized bone. It is equal to Osteoid Volume (OV) divided by Bone Volume (BV).
Measured: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of a given volume of tissue (bone + marrow) that consists of unmineralized bone. It is equal to Osteoid Volume (OV) divided by Tissue Volume (TV).
Measured: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of bone surface that consists of unmineralized bone. It is equal to Osteoid Surface (OS) divided by Bone Surface (BS).
Measured: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized. Bone mass is a balance between the osteoblasts (OB) that form the bone and cells called osteoclasts (OC) that break down the bone. The reported values indicate the percent of bone surface (BS) that is made up of osteoblasts (OB).
Measured: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones. Osteoclasts make and secrete digestive enzymes that break up or dissolve the bone tissue. Bone mass is a balance between the osteoblasts (OB) cells that form the bone and the osteoclasts (OC) cells that break down the bone. The reported values indicate the percent of bone surface (BS) that consists of osteoclasts (OC).
Measured: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones. Osteoclasts make and secret digestive enzymes tha break up or dissolve the bone tissue. An eroded surface (ES) is the surface of the lacuna ( a cavity or depression in the bone) generated by an active OC. The reported values indicate the percent of eroded surface relative to bone surface (BS).
Measured: Baseline and month 12 of the treatment
Bone Histomorphometry - Bone Formation Rate
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized. Bone formation rate (BFR) indicates how much of the bone is actively mineralizing; it is determined by the number of active OB and the average work of each OB.
Measured: Baseline and month 12 of the treatment
Bone Histomorphometry - Osteoid Volume (OV)
Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the Osteoid Volume (OV), the volume of bone that consists of unmineralized bone.
Measured: Baseline and month 12 of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2002Jul 2008

First posted19 Dec 2005 (estimated)
Study startOct 2002
Primary completionJul 2008
Study completionJul 2008

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal Transplant OsteodystrophyStudies of the same condition, open and under way.
More trials run by Montefiore Medical CenterThe 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00266708
Sponsor's protocol ID: 02-08-224
Status last verified: Feb 2019
First submitted: 15 Dec 2005
Last updated: 1 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes

Publications

Coco M, Pullman J, Cohen HW, Lee S, Shapiro C, Solorzano C, Greenstein S, Glicklich D. Effect of risedronate on bone in renal transplant recipients. J Am Soc Nephrol. 2012 Aug;23(8):1426-37. doi: 10.1681/ASN.2011060623. Epub 2012 Jul 12.
PubMed 22797188

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant
ClinicalTrials.gov ID: NCT00266708
Acronym / sponsor ID: 02-08-224
Conditions: Renal Transplant Osteodystrophy
Keywords: renal transplant, post-transplant osteoporosis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: Oct 2002
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 19 Dec 2005 (estimated)
Results: Posted 1 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Risedronate	Experimental	Drug: Risedronatesubjects received Risedronate for one year
subjects received placebo	Placebo comparator	Drug: Placebosubjects received placebo for 1 year

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adults with end stage renal disease who are undergoing living donor kidney transplantation

Key exclusion criteria (0 listed)

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
RisedronateAlso: bisphosphonaterisedronate 35 mg weekly	Drug	Risedronate
PlaceboAlso: Risedronate placeboRisedronate Placebo 35 mg weekly	Drug	subjects received placebo

Primary outcome

Bone Mineral Density of Spine at 6 Months
Time frame: month 6 of the treatment
Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner.
Bone Mineral Density of Spine at 12 Months
Time frame: month 12 of treatment
Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using same Hologic 4500 QDC scanner.
Bone Mineral Density of the Hip at 6 Months
Time frame: month 6 of the treatment
Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
Bone Mineral Density of the Hip at 12 Months
Time frame: month 12 of the treatment
Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner.
Bone Mineral Density of Forearm at 6 Months
Time frame: month 6 of the treatment
Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.
Bone Mineral Density of Forearm at 12 Months
Time frame: month 12 of the treatment
Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner.

12 secondary outcomes

Bone Histomorphometry - Percent Bone Volume (BV/TV)
Time frame: Baseline and month 12 of the treatment
Bone Histomorphometry - Trabecular Thickness (TbTh)
Time frame: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)
Time frame: Baseline and month 12 of the treatment
Bone Histomorphometry - Mineralized Bone Volume (MdV)
Time frame: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)
Time frame: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)
Time frame: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)
Time frame: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)
Time frame: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)
Time frame: Baseline and month 12 of the treatment
Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)
Time frame: Baseline and month 12 of the treatment
Bone Histomorphometry - Bone Formation Rate
Time frame: Baseline and month 12 of the treatment
Bone Histomorphometry - Osteoid Volume (OV)
Time frame: Baseline and month 12 of the treatment

Results and safety

Results posted to the registry on 1 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Risedronate	20	16
Placebo	22	13

Primary outcome: Bone Mineral Density of Spine at 6 Months

Time frame: month 6 of the treatment. Mean (Standard Deviation). Unit: gm/cm^2

Measure	Risedronate n = 20	Placebo n = 22
Value	0.98 (0.16)	0.97 (0.14)

Population analysed: Calculation done on intent-to-treat population

Primary outcome: Bone Mineral Density of Spine at 12 Months

Time frame: month 12 of treatment. Mean (Standard Deviation). Unit: gm/cm^2

Measure	Risedronate n = 20	Placebo n = 22
Value	1.00 (0.18)	1.00 (0.18)

Population analysed: Calculation done on intent-to-treat population

Primary outcome: Bone Mineral Density of the Hip at 6 Months

Time frame: month 6 of the treatment. Mean (Standard Deviation). Unit: gm/cm^2

Measure	Risedronate n = 20	Placebo n = 22
Value	0.88 (0.13)	0.86 (0.13)

Population analysed: Calculation done on intent-to-treat population

Primary outcome: Bone Mineral Density of the Hip at 12 Months

Time frame: month 12 of the treatment. Mean (Standard Deviation). Unit: gm/cm^2

Measure	Risedronate n = 20	Placebo n = 22
Value	0.91 (0.13)	0.87 (0.15)

Population analysed: Calculation done on intent-to-treat population

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events collected during course of study, which lasted 6 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Risedronate	1 of 20 (5%)	0 of 20 (0%)	0 of 20
Placebo	0 of 20 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22797188Coco M, Pullman J, Cohen HW, Lee S, Shapiro C, Solorzano C, Greenstein S, Glicklich D. Effect of risedronate on bone in renal transplant recipients. J Am Soc Nephrol. 2012 Aug;23(8):1426-37. doi: 10.1681/ASN.2011060623. Epub 2012 Jul 12.

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.

Maria Coco, MD, MS principal investigator

Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Risedronate in people with Renal Transplant Osteodystrophy, run by Montefiore Medical Center 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 1 inclusion and 0 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 1 Mar 2019. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 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?

Bone Mineral Density of Spine at 6 Months (time frame: month 6 of the treatment). The study lists 6 primary outcomes in all. 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 NCT00266708, which also lists 1 linked publication.

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 1 Mar 2019.