Trial Outcomes & Findings for Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation (NCT NCT02074631)
NCT ID: NCT02074631
Last Updated: 2024-02-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
1 year after HCT
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
Control Group
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
30
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation
Baseline characteristics by cohort
| Measure |
Control Group
n=32 Participants
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=31 Participants
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year after HCTPopulation: Participants unable to be evaluated due to declining health or failure of follow up.
Outcome measures
| Measure |
Control Group
n=29 Participants
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=23 Participants
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Lumbar Spine Bone Mineral Content
|
41.4 Average grams
Standard Deviation 22.8
|
38.7 Average grams
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: 1 year after HCTPopulation: Participants unable to be evaluated due to declining health or failure of follow up.
Outcome measures
| Measure |
Control Group
n=28 Participants
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=20 Participants
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Total Body Bone Mineral Content (TBMC; Excluding Head; Adjusted for Height, Age, Sex, Tanner Stage, and Race)
|
1231 Average grams
Standard Error 95
|
1204 Average grams
Standard Error 113
|
SECONDARY outcome
Timeframe: 1 year after HCTPopulation: Participants unable to be evaluated due to declining health or failure of follow up.
Measured in g/cm2.
Outcome measures
| Measure |
Control Group
n=29 Participants
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=21 Participants
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Total Bone Mineral Density (BMD), Cortical BMD, Trabecular BMD, and Estimated Bone Strength Measured by pQCT
|
0.829 g/cm2
Standard Deviation 0.202
|
0.760 g/cm2
Standard Deviation 0.189
|
SECONDARY outcome
Timeframe: 7 days, 14 days, 21 days, 90 days after HCTPopulation: Participants unable to be evaluated due to declining health or failure of follow up.
Measured in pg/ml.
Outcome measures
| Measure |
Control Group
n=28 Participants
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=27 Participants
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
IL-6 7 days after HCT
|
37.4 pg/ml
Standard Deviation 46.6
|
41.4 pg/ml
Standard Deviation 49.4
|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
IL-6 14 days after HCT
|
23.6 pg/ml
Standard Deviation 19.9
|
35.4 pg/ml
Standard Deviation 32.7
|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
IL-6 21 days after HCT
|
22.0 pg/ml
Standard Deviation 63.9
|
18.1 pg/ml
Standard Deviation 17.5
|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
IL-6 90 days after HCT
|
10.7 pg/ml
Standard Deviation 33.9
|
6.8 pg/ml
Standard Deviation 5.0
|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
IL-7 7 days after HCT
|
35.8 pg/ml
Standard Deviation 15.6
|
33.4 pg/ml
Standard Deviation 19.3
|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
IL-7 14 days after HCT
|
33.7 pg/ml
Standard Deviation 14.7
|
35.9 pg/ml
Standard Deviation 27.4
|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
IL-7 21 days after HCT
|
28.8 pg/ml
Standard Deviation 15.7
|
31.5 pg/ml
Standard Deviation 25.9
|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
IL-7 90 days after HCT
|
11.4 pg/ml
Standard Deviation 9.5
|
13.1 pg/ml
Standard Deviation 11.6
|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
TNFa 7 days after HCT
|
7.0 pg/ml
Standard Deviation 2.8
|
6.9 pg/ml
Standard Deviation 3.4
|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
TNFa 14 days after HCT
|
10.5 pg/ml
Standard Deviation 5.6
|
11.4 pg/ml
Standard Deviation 9.4
|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
TNFa 21 days after HCT
|
11.3 pg/ml
Standard Deviation 5.7
|
12.7 pg/ml
Standard Deviation 7.2
|
|
Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)
TNFa 90 days after HCT
|
14.3 pg/ml
Standard Deviation 6.5
|
15.9 pg/ml
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 7 days, 14 days, 21 days, and 90 days after HCTPopulation: Participants unable to be evaluated due to declining health or failure of follow up.
Measured in pg/ml.
Outcome measures
| Measure |
Control Group
n=27 Participants
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=27 Participants
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Receptor Activator of the Nuclear Factor-κB Ligand [RANKL], Osteoprotegerin [OPG]
OPG 90 days after HCT
|
499 pg/ml
Standard Deviation 589
|
422 pg/ml
Standard Deviation 231
|
|
Receptor Activator of the Nuclear Factor-κB Ligand [RANKL], Osteoprotegerin [OPG]
RANKL 7 days after HCT
|
58.9 pg/ml
Standard Deviation 72.4
|
40.5 pg/ml
Standard Deviation 36.3
|
|
Receptor Activator of the Nuclear Factor-κB Ligand [RANKL], Osteoprotegerin [OPG]
RANKL 14 days after HCT
|
45.5 pg/ml
Standard Deviation 64.6
|
42.1 pg/ml
Standard Deviation 44.7
|
|
Receptor Activator of the Nuclear Factor-κB Ligand [RANKL], Osteoprotegerin [OPG]
RANKL 21 days after HCT
|
49.3 pg/ml
Standard Deviation 55.8
|
51.0 pg/ml
Standard Deviation 48.6
|
|
Receptor Activator of the Nuclear Factor-κB Ligand [RANKL], Osteoprotegerin [OPG]
RANKL 90 days after HCT
|
56.6 pg/ml
Standard Deviation 65.8
|
41.4 pg/ml
Standard Deviation 27.5
|
|
Receptor Activator of the Nuclear Factor-κB Ligand [RANKL], Osteoprotegerin [OPG]
OPG 7 days after HCT
|
489 pg/ml
Standard Deviation 454
|
564 pg/ml
Standard Deviation 315
|
|
Receptor Activator of the Nuclear Factor-κB Ligand [RANKL], Osteoprotegerin [OPG]
OPG 14 days after HCT
|
617 pg/ml
Standard Deviation 651
|
650 pg/ml
Standard Deviation 378
|
|
Receptor Activator of the Nuclear Factor-κB Ligand [RANKL], Osteoprotegerin [OPG]
OPG 21 days after HCT
|
582 pg/ml
Standard Deviation 646
|
575 pg/ml
Standard Deviation 290
|
SECONDARY outcome
Timeframe: 7, 14, 21, 90, 180, 360 days after HCTPopulation: Participants unable to be evaluated due to declining health or failure of follow up.
CTX measured in ng/ml.
Outcome measures
| Measure |
Control Group
n=28 Participants
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=27 Participants
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Marker of Bone Resorption (Carboxy-terminal Collagen Crosslinks [CTX]
CTX 7 days after HCT
|
0.596 ng/ml
Standard Deviation 0.833
|
0.455 ng/ml
Standard Deviation 0.440
|
|
Marker of Bone Resorption (Carboxy-terminal Collagen Crosslinks [CTX]
CTX 14 days after HCT
|
0.341 ng/ml
Standard Deviation 0.165
|
0.347 ng/ml
Standard Deviation 0.185
|
|
Marker of Bone Resorption (Carboxy-terminal Collagen Crosslinks [CTX]
CTX 21 days after HCT
|
0.332 ng/ml
Standard Deviation 0.085
|
0.441 ng/ml
Standard Deviation 0.372
|
|
Marker of Bone Resorption (Carboxy-terminal Collagen Crosslinks [CTX]
CTX 90 days after HCT
|
0.327 ng/ml
Standard Deviation 0.117
|
0.328 ng/ml
Standard Deviation 0.113
|
|
Marker of Bone Resorption (Carboxy-terminal Collagen Crosslinks [CTX]
CTX 180 days after HCT
|
0.395 ng/ml
Standard Deviation 0.236
|
0.318 ng/ml
Standard Deviation 0.106
|
|
Marker of Bone Resorption (Carboxy-terminal Collagen Crosslinks [CTX]
CTX 360 days after HCT
|
0.291 ng/ml
Standard Deviation 0.119
|
0.307 ng/ml
Standard Deviation 0.088
|
SECONDARY outcome
Timeframe: 7, 14, 21, 90, 180, 360 days after HCTPopulation: Participants unable to be evaluated due to declining health or failure of follow up.
P1NP measured in ng/ml.
Outcome measures
| Measure |
Control Group
n=28 Participants
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=27 Participants
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Markers of Bone Formation (Procollagen Type 1 N-terminal Propeptide [P1NP])
P1NP 7 days after HCT
|
36.2 ng/ml
Standard Deviation 14.9
|
38 ng/ml
Standard Deviation 18.6
|
|
Markers of Bone Formation (Procollagen Type 1 N-terminal Propeptide [P1NP])
P1NP 14 days after HCT
|
36.9 ng/ml
Standard Deviation 16.8
|
35.7 ng/ml
Standard Deviation 14.2
|
|
Markers of Bone Formation (Procollagen Type 1 N-terminal Propeptide [P1NP])
P1NP 21 days after HCT
|
38.5 ng/ml
Standard Deviation 16.4
|
37.1 ng/ml
Standard Deviation 15.4
|
|
Markers of Bone Formation (Procollagen Type 1 N-terminal Propeptide [P1NP])
P1NP 90 days after HCT
|
41.2 ng/ml
Standard Deviation 17.9
|
39.5 ng/ml
Standard Deviation 17.8
|
|
Markers of Bone Formation (Procollagen Type 1 N-terminal Propeptide [P1NP])
P1NP 180 days after HCT
|
29.2 ng/ml
Standard Deviation 13.7
|
27.6 ng/ml
Standard Deviation 11.8
|
|
Markers of Bone Formation (Procollagen Type 1 N-terminal Propeptide [P1NP])
P1NP 360 days after HCT
|
28.6 ng/ml
Standard Deviation 14.5
|
29.3 ng/ml
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: 7 days, 14 days, 21 days, and 90 days after HCTPopulation: Participants unable to be evaluated due to declining health or failure of follow up.
Outcome measures
| Measure |
Control Group
n=25 Participants
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=26 Participants
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Ratio of Receptor Activator of the Nuclear Factor-κB Ligand [RANKL] and Osteoprotegerin [OPG]
RANKL/OPG 7 days after HCT
|
0.154 ratio
Standard Deviation 0.186
|
0.096 ratio
Standard Deviation 0.103
|
|
Ratio of Receptor Activator of the Nuclear Factor-κB Ligand [RANKL] and Osteoprotegerin [OPG]
RANKL/OPG 14 days after HCT
|
0.10 ratio
Standard Deviation 0.137
|
0.078 ratio
Standard Deviation 0.085
|
|
Ratio of Receptor Activator of the Nuclear Factor-κB Ligand [RANKL] and Osteoprotegerin [OPG]
RANKL/OPG 21 days after HCT
|
0.121 ratio
Standard Deviation 0.139
|
0.095 ratio
Standard Deviation 0.086
|
|
Ratio of Receptor Activator of the Nuclear Factor-κB Ligand [RANKL] and Osteoprotegerin [OPG]
RANKL/OPG 90 days after HCT
|
0.205 ratio
Standard Deviation 0.278
|
0.127 ratio
Standard Deviation 0.109
|
SECONDARY outcome
Timeframe: 7, 14, 21, 90, 180, 360 days after HCTPopulation: Participants unable to be evaluated due to declining health or failure of follow up.
DPD measured in mmol/L.
Outcome measures
| Measure |
Control Group
n=28 Participants
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=27 Participants
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Marker of Bone Resorption Deoxypyridinoline [DPD])
DPD 7 days after HCT
|
133 mmol/L
Standard Deviation 113
|
89.7 mmol/L
Standard Deviation 58.8
|
|
Marker of Bone Resorption Deoxypyridinoline [DPD])
DPD 14 days after HCT
|
71.4 mmol/L
Standard Deviation 65.7
|
70.7 mmol/L
Standard Deviation 58.7
|
|
Marker of Bone Resorption Deoxypyridinoline [DPD])
DPD 21 days after HCT
|
91.6 mmol/L
Standard Deviation 78.8
|
112 mmol/L
Standard Deviation 103
|
|
Marker of Bone Resorption Deoxypyridinoline [DPD])
DPD 90 days after HCT
|
170 mmol/L
Standard Deviation 130
|
146 mmol/L
Standard Deviation 108
|
|
Marker of Bone Resorption Deoxypyridinoline [DPD])
DPD 180 days after HCT
|
191 mmol/L
Standard Deviation 119
|
163 mmol/L
Standard Deviation 107
|
|
Marker of Bone Resorption Deoxypyridinoline [DPD])
DPD 360 days after HCT
|
123 mmol/L
Standard Deviation 87
|
145 mmol/L
Standard Deviation 121
|
SECONDARY outcome
Timeframe: 7, 14, 21, 90, 180, 360 days after HCTPopulation: Participants unable to be evaluated due to declining health or failure of follow up.
OCN measured in pg/ml.
Outcome measures
| Measure |
Control Group
n=26 Participants
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=27 Participants
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Marker of Bone Formation Osteocalcin [OCN])
OCN 7 days after HCT
|
56832 pg/ml
Standard Deviation 31576
|
59071 pg/ml
Standard Deviation 31740
|
|
Marker of Bone Formation Osteocalcin [OCN])
OCN 14 days after HCT
|
57611 pg/ml
Standard Deviation 37994
|
68137 pg/ml
Standard Deviation 41600
|
|
Marker of Bone Formation Osteocalcin [OCN])
OCN 21 days after HCT
|
59890 pg/ml
Standard Deviation 37398
|
58983 pg/ml
Standard Deviation 42097
|
|
Marker of Bone Formation Osteocalcin [OCN])
OCN 90 days after HCT
|
48839 pg/ml
Standard Deviation 33380
|
57638 pg/ml
Standard Deviation 34727
|
|
Marker of Bone Formation Osteocalcin [OCN])
OCN 180 days after HCT
|
47077 pg/ml
Standard Deviation 45972
|
47459 pg/ml
Standard Deviation 18955
|
|
Marker of Bone Formation Osteocalcin [OCN])
OCN 360 days after HCT
|
85950 pg/ml
Standard Deviation 126169
|
52972 pg/ml
Standard Deviation 25938
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Pamidronate Group
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group
n=32 participants at risk
Subjects will receive a standard recommended dose of calcium and vitamin D.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
Pamidronate Group
n=31 participants at risk
Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.
Pamidronate: Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
Calcium and vitamin D: All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
|
|---|---|---|
|
Cardiac disorders
Heart palpitations
|
0.00%
0/32 • 1 year
|
6.5%
2/31 • Number of events 2 • 1 year
|
|
Cardiac disorders
Chest pain
|
0.00%
0/32 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
|
Eye disorders
Redness of the eye
|
3.1%
1/32 • Number of events 1 • 1 year
|
0.00%
0/31 • 1 year
|
|
Eye disorders
Blurred vision
|
0.00%
0/32 • 1 year
|
6.5%
2/31 • Number of events 3 • 1 year
|
|
Eye disorders
Photophobia
|
0.00%
0/32 • 1 year
|
3.2%
1/31 • Number of events 2 • 1 year
|
|
Eye disorders
Eye pain
|
0.00%
0/32 • 1 year
|
3.2%
1/31 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
9.4%
3/32 • Number of events 3 • 1 year
|
6.5%
2/31 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/32 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
9.4%
3/32 • Number of events 3 • 1 year
|
19.4%
6/31 • Number of events 9 • 1 year
|
|
Skin and subcutaneous tissue disorders
Itching
|
6.2%
2/32 • Number of events 2 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/32 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/32 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
Additional Information
Dr. Kyriakie Sarafoglou
University of Minnesota, Masonic Cancer Center
Phone: (612) 624-5965
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place