Trial Outcomes & Findings for Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture (NCT NCT01950169)

NCT ID: NCT01950169

Last Updated: 2021-04-14

Results Overview

Total hip bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm\^2). The change in BMD between baseline, 6 and 12 months was registered.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 79 participants
• Primary outcome timeframe: Baseline, 6 months and 12 months
• Results posted on: 2021-04-14

Participant Flow

Participant milestones

Measure	Group B, Bisphosphonates Patients allocated to intervention B received 35 mg risedronate once weekly for 12 months and 1,000 mg calcium and 800 IU vitamin D3 daily.	Group BN/N, Bisphosphonates Along With Nutritional Supplementation Patients allocated to intervention BN/N received 35 mg risedronate once weekly for 12 months plus a nutritional supplement (Fresubin protein energy drink) during the first 6 months after hip fracture. The supplement contained 150 kcal and 10 g protein/100 mL milk-based protein (80 % casein and 20 % whey). Patients were prescribed 200 mL twice daily, totaling 600 kcal with 40 g protein.	Group C, Control Patients allocated to group C served as controls and received 1,000 mg Calcium and 800 IU vitamin D3 daily for 12 months.
Overall Study STARTED	28	26	25
Overall Study COMPLETED	25	18	24
Overall Study NOT COMPLETED	3	8	1

Reasons for withdrawal

Measure	Group B, Bisphosphonates Patients allocated to intervention B received 35 mg risedronate once weekly for 12 months and 1,000 mg calcium and 800 IU vitamin D3 daily.	Group BN/N, Bisphosphonates Along With Nutritional Supplementation Patients allocated to intervention BN/N received 35 mg risedronate once weekly for 12 months plus a nutritional supplement (Fresubin protein energy drink) during the first 6 months after hip fracture. The supplement contained 150 kcal and 10 g protein/100 mL milk-based protein (80 % casein and 20 % whey). Patients were prescribed 200 mL twice daily, totaling 600 kcal with 40 g protein.	Group C, Control Patients allocated to group C served as controls and received 1,000 mg Calcium and 800 IU vitamin D3 daily for 12 months.
Overall Study Withdrawal by Subject	2	8	1
Overall Study Death	1	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group B, Bisphosphonate n=28 Participants Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.	Group BN/N, Bisphosphonates Along With Nutritional Supplementation n=26 Participants Patients allocated to intervention BN/N received 35 mg risedronate once weekly for 12 months plus a nutritional supplement (Fresubin protein energy drink) during the first 6 months after hip fracture. The supplement contained 150 kcal and 10 g protein/100 mL milk-based protein (80 % casein and 20 % whey). Patients were prescribed 200 mL twice daily, totaling 600 kcal with 40 g protein.	C, Control n=25 Participants Patients allocated to group C served as controls and received 1,000 mg Calcium and 800 IU vitamin D3 daily for 12 months.	Total n=79 Participants Total of all reporting groups
Age, Continuous	82 Years n=28 Participants	82 Years n=26 Participants	75 Years n=25 Participants	81 Years n=79 Participants
Sex: Female, Male Female	18 Participants n=28 Participants	19 Participants n=26 Participants	19 Participants n=25 Participants	56 Participants n=79 Participants
Sex: Female, Male Male	10 Participants n=28 Participants	7 Participants n=26 Participants	6 Participants n=25 Participants	23 Participants n=79 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	28 participants n=28 Participants	26 participants n=26 Participants	25 participants n=25 Participants	79 participants n=79 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months and 12 months

Population: Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up.

Total hip bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm^2). The change in BMD between baseline, 6 and 12 months was registered.

Outcome measures

Measure	B, Bisphosphonate n=28 Participants Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.	BN/N, Bisphosphonate Along With Nutritional Supplementation n=26 Participants Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).	C, Control n=25 Participants The patients were randomized to receive calcium and vitamin D3 alone and served as controls.
Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. follow up at 6 months	-0.008 g/cm^2 Standard Deviation 0.037	0.005 g/cm^2 Standard Deviation 0.026	-0.017 g/cm^2 Standard Deviation 0.026
Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. follow up at 12 months	-0.012 g/cm^2 Standard Deviation 0.042	-0.004 g/cm^2 Standard Deviation 0.025	-0.018 g/cm^2 Standard Deviation 0.032

PRIMARY outcome

Timeframe: Baseline, 6 months and 12 months

Population: Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up.

Total body mineral density (BMD) were assessed by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm^2). The change in BMD between baseline, 6 and 12 months was registered.

Outcome measures

Measure	B, Bisphosphonate n=28 Participants Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.	BN/N, Bisphosphonate Along With Nutritional Supplementation n=26 Participants Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).	C, Control n=25 Participants The patients were randomized to receive calcium and vitamin D3 alone and served as controls.
Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. follow-up at 6 months	-0.005 g/cm^2 Standard Deviation 0.018	-0.006 g/cm^2 Standard Deviation 0.018	-0.012 g/cm^2 Standard Deviation 0.019
Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture. follow-up at 12 months	-0.003 g/cm^2 Standard Deviation 0.022	0.0006 g/cm^2 Standard Deviation 0.019	-0.017 g/cm^2 Standard Deviation 0.020

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up. Calculations revealed that a sample size of 40 patients per group was required to detect a difference in lean mass between groups (power = 80 %, a = 0.05). However, the study was closed after 4 years due to difficulties in recruiting patients and the study was switched to an exploratory design.

Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up. The sum of lean mass (LM) and BMC represents fat-free mass (FFM). To normalize for body size, FFM was divided by height squared to calculate fat-free mass index (FFMI, kg/m^2).

Outcome measures

Measure	B, Bisphosphonate n=28 Participants Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.	BN/N, Bisphosphonate Along With Nutritional Supplementation n=26 Participants Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).	C, Control n=25 Participants The patients were randomized to receive calcium and vitamin D3 alone and served as controls.
Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture. follow up at 6 months	-0.4 kg/m^2 Standard Deviation 1.2	-0.9 kg/m^2 Standard Deviation 0.7	-0.4 kg/m^2 Standard Deviation 0.8
Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture. follow up at 12 months	-0.5 kg/m^2 Standard Deviation 1.2	-0.8 kg/m^2 Standard Deviation 0.9	-0.5 kg/m^2 Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up. Calculations revealed that a sample size of 40 patients per group was required to detect a difference in lean mass between groups (power = 80 %, a = 0.05). However, the study was closed after 4 years due to difficulties in recruiting patients and the study was switched to an exploratory design.

Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up.To normalize for body size, FM was divided by height squared to calculate fat mass index (FMI, kg/m^2).

Outcome measures

Measure	B, Bisphosphonate n=28 Participants Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.	BN/N, Bisphosphonate Along With Nutritional Supplementation n=26 Participants Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).	C, Control n=25 Participants The patients were randomized to receive calcium and vitamin D3 alone and served as controls.
Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture. follow up at 6 months	-0.6 kg/m^2 Standard Deviation 1.4	0.1 kg/m^2 Standard Deviation 0.8	-0.1 kg/m^2 Standard Deviation 0.8
Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture. follow up at 12 months	-0.3 kg/m^2 Standard Deviation 1.6	0.1 kg/m^2 Standard Deviation 0.8	-0.1 kg/m^2 Standard Deviation 1.1

Adverse Events

B, Bisphosphonate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

BN/N, Bisphosphonate Along With Nutritional Supplementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

C, Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	B, Bisphosphonate n=28 participants at risk Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.	BN/N, Bisphosphonate Along With Nutritional Supplementation n=26 participants at risk Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).	C, Control n=25 participants at risk The patients were randomized to receive calcium and vitamin D3 alone and served as controls.
Gastrointestinal disorders Constipation/diarrhea	7.1% 2/28 • Adverse event data were collected 1 year for every patient included. Once a month the study research nurse interviewed patients by telephone regarding compliance, general state of health and collected adverse event information.	0.00% 0/26 • Adverse event data were collected 1 year for every patient included. Once a month the study research nurse interviewed patients by telephone regarding compliance, general state of health and collected adverse event information.	12.0% 3/25 • Adverse event data were collected 1 year for every patient included. Once a month the study research nurse interviewed patients by telephone regarding compliance, general state of health and collected adverse event information.

Additional Information

Dr. Lena Flodin

Department of Geriatric Medicine, Karolinska University Hospital, Stockholm, Sweden

Phone: Mobile: 0701910300

Email: lena.flodin@sll.se

Results disclosure agreements

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