Background: Osteopenia and osteoporosis are frequent complications of HIV infection and/or its treatment. Alendronate is the only bisphosphonate approved for the treatment of osteoporosis in men and women. We conducted a 48 wk prospective, randomized, open label study to evaluate the effects of alendronate, vit D and calcium supplementation on bone mineral density (BMD) in patients (pts) with HIV infection.

Methods: Thirty-one (31) HIV infected subjects on ART for a minimum of 6 months (mos) with lumbar spine BMD t scores less than -1.0, were randomized to receive 70 mg of alendronate (n = 15) or not (n = 16) weekly for 48 wks. All subjects received in addition calcium (1000 mg daily as calcium carbonate) and vit D (400 IU daily). The study was powered to detect 3% changes in BMD in the lumbar spine within arms.

Results: Pts were 87% male, 80% Caucasian, 29% smokers, and 16% moderate drinkers. Sixty-one percent (61%) were on PI based regimens. The mean age was 44 yrs, and mean BMI was 25 kg/m². Average length of HIV infection was 8 yrs, 84% had viral load below 400 copies/ml, current CD4⁺ T-cell count was 561 cells/µl (median nadir CD4 count 167 cells/µl). At baseline, median lumbar spine BMD t-score was -1.52, and median hip t-score was -1.02. Treatment effects are shown in the table:

 

		Alendronate + Vit D + Ca Mean ± SE % change from baseline	P value within	Vit D + Ca Mean ± SE % change from baseline	P value within	% Difference between groups (95% CI)	P value between
BMD	Spine	5.2 ± 0.7	<.0001	1.3 ± 1.0	.240	3.8 (1.3 to 6.4)	.005
	Neck	2.4 ±1.4	.117	1.6 ± 0.8	.075	0.8 (-2.4 to 4.0)	.610
	Trochanter	1.4 ± 1.3	.338	0.8 ± 0.8	.341	0.6 (-2.4 to 3.6)	.689
	Hip	2.3 ± 1.0	.044	1.7 ± 0.6	.017	0.5 (-1.8 to 2.9)	.643
	Total body	0.9 ± 0.5	.093	0.0 ± 0.7	.895	0.9 (-0.8 to 2.7)	.288
Bone Alk. Phosp.		-31 ± 3	.001	-16 ± 6	.035	-15 (-29 to -1)	.031
Urine Deoxypyr.		-46 ± 14	.032	-28 ± 9	.021	-18 (-52 to 16)	.267

 

One subject discontinued treatment in each arm. There were no serious adverse events.

Conclusions: Alendronate, vit D, and calcium are safe and effective in the treatment of osteopenia/osteoporosis associated with HIV infection. Alendronate in combination with vit D and calcium increased lumbar spine BMD by 5.2% at 48 wks vs 1.3% of vit D and calcium alone. These results are consistent with the results observed in HIV^-  individuals. These data provide the basis for sample size calculations and support the evaluation of alendronate in larger randomized trials.