Trial Outcomes & Findings for Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants (NCT NCT00580047)

NCT ID: NCT00580047

Last Updated: 2023-10-04

Results Overview

Posterior Anterior (PA) spine bone density was measured by dual energy x-ray absorptiometry (DXA) at baseline and 24 months post transplant. The percentage change in the PA spine bone density was then compared from baseline to 24 months post transplant.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2023-10-04

Participant Flow

All patients from the Kidney Pancreas Transplant clinic at the University of Nebraska Medical Center who underwent a kidney, pancreas, or kidney-pancreas transplant from 2003 to 2009 were invited to participate.

Participants were recruited during the transplant hospitalization or within 30 days of transplantation. They were excluded if they had an esophageal abnormality, bone density T-score of -3 or lower, fracture in the last 2 years, Cr Cl of 35 or less, inability to sit upright for 30 minutes after swallowing a medication.

Participant milestones

Measure	Intravenous Bisphosphonate Post Transplantation Zoledronic Acid 4mg Zoledronic Acid: 4mg IV Annually	Oral Bisphosphonate Post Transplantation Alendronate 70mg Alendronate: 70mg weekly	Placebo Group Post Transplantation Calcium 1200mg Vitamin D 800IU calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D
Overall Study STARTED	24	23	12
Overall Study COMPLETED	21	21	10
Overall Study NOT COMPLETED	3	2	2

Reasons for withdrawal

Measure	Intravenous Bisphosphonate Post Transplantation Zoledronic Acid 4mg Zoledronic Acid: 4mg IV Annually	Oral Bisphosphonate Post Transplantation Alendronate 70mg Alendronate: 70mg weekly	Placebo Group Post Transplantation Calcium 1200mg Vitamin D 800IU calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D
Overall Study Lost to Follow-up	1	1	0
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants

Baseline characteristics by cohort

Measure	Intravenous Bisphosphonate Post Transplantation n=24 Participants Zoledronic Acid 4mg Zoledronic Acid: 4mg IV Annually	Oral Bisphosphonate Post Tranpslantation n=23 Participants Alendronate 70mg Alendronate: 70mg weekly	Placebo Post Transplantation n=12 Participants Calcium 1200mg Vitamin D 800IU calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D	Total n=59 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 11 • n=5 Participants	50 years STANDARD_DEVIATION 15 • n=7 Participants	46 years STANDARD_DEVIATION 12 • n=5 Participants	47 years STANDARD_DEVIATION 12 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	39 Participants n=4 Participants
Region of Enrollment United States	24 Participants n=5 Participants	23 Participants n=7 Participants	12 Participants n=5 Participants	59 Participants n=4 Participants
Spine bone density	1.5 grams/cm2 STANDARD_DEVIATION 0.03 • n=5 Participants	1.28 grams/cm2 STANDARD_DEVIATION 0.046 • n=7 Participants	1.12 grams/cm2 STANDARD_DEVIATION 0.05 • n=5 Participants	1.3 grams/cm2 STANDARD_DEVIATION .05 • n=4 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Percentage change in spine bone density from baseline to 24 months

Posterior Anterior (PA) spine bone density was measured by dual energy x-ray absorptiometry (DXA) at baseline and 24 months post transplant. The percentage change in the PA spine bone density was then compared from baseline to 24 months post transplant.

Outcome measures

Measure	Intravenous Bisphosphonate Post Transplantation n=24 Participants Zoledronic Acid 4mg Zoledronic Acid: 4mg IV Annually 8% increase	Oral Bisphosphonate Post Transplantation n=23 Participants Alendronate 70mg Alendronate: 70mg weekly 8% increase	Placebo Group Post Transplantation n=12 Participants Calcium 1200mg Vitamin D 800IU calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D 8% increase
Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant	8.1 percentage of change of bone density	6.6 percentage of change of bone density	6.5 percentage of change of bone density

SECONDARY outcome

Timeframe: 24 months

Population: Compliance in study arm

Compare compliance where a study coordinator interviewed patients as to how often they missed the once a week oral alendronate, missed taking calcium and vitamin D supplementation, or missed the once a year IV Reclast.

Outcome measures

Measure	Intravenous Bisphosphonate Post Transplantation n=24 Participants Zoledronic Acid 4mg Zoledronic Acid: 4mg IV Annually 8% increase	Oral Bisphosphonate Post Transplantation n=23 Participants Alendronate 70mg Alendronate: 70mg weekly 8% increase	Placebo Group Post Transplantation n=12 Participants Calcium 1200mg Vitamin D 800IU calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D 8% increase
Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation	100 percentage of compliance	80 percentage of compliance	80 percentage of compliance

Adverse Events

Intravenous Bisphosphonate After Tranpslant

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Oral Bisphosphonate After Transplant

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo After Transplant

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intravenous Bisphosphonate After Tranpslant n=24 participants at risk Zoledronic Acid 4mg Zoledronic Acid: 4mg IV Annually	Oral Bisphosphonate After Transplant n=23 participants at risk Alendronate 70mg Alendronate: 70mg weekly	Placebo After Transplant n=12 participants at risk Calcium 1200mg Vitamin D 800IU calcium and Vitamin D: 1200 mg Calcium 800 International Units Vitamin D
Gastrointestinal disorders dyspepsia	0.00% 0/24 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events	8.7% 2/23 • Number of events 2 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events	0.00% 0/12 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events
Musculoskeletal and connective tissue disorders muscle pain	8.3% 2/24 • Number of events 2 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events	0.00% 0/23 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events	0.00% 0/12 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events
Gastrointestinal disorders constipation	0.00% 0/24 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events	8.7% 2/23 • Number of events 2 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events	0.00% 0/12 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events
Gastrointestinal disorders flatulence	0.00% 0/24 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events	0.00% 0/23 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events	16.7% 2/12 • Number of events 2 • 2 years A study coordinator helped the patient complete a questionnaire of potential side effects/adverse events

Additional Information

Lynn Mack

University of Nebraska Medical Center

Phone: 402-559-6208

Email: lmack@unmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place